Implementing E-Records & E-Signatures in Oracle Applications

8/10/2019 Implementing E-Records & E-Signatures in Oracle Applications

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Implementing E-Records and E-Signatures (11.5.10) in DiscreteManufacturing Suite

Part 11 applies to electronic records required under a predicate rule, e.g., QSR, GLP, etc. It is notintended to increase the number of records maintained by a regulated company. It is intended to place

some requirements on the retention of the records to ensure their usefulness and integrity. Many of the

informal interpretations that have been discussed over the past several years would increase significantly

the amount of data retained by regulated industries clearly contravening the intent of the rule. We believethat our proposal would limit the amount of retained data to that which is truly needed to satisfy both

business and regulatory purposes.

William W. Bradley

Chairman, Steering Committee

Industry Coalition on 21 CFR Part 11

Docket 00D-1541 (June 14, 2002)

ABSTRACT

Oracle E-Records is a configurable framework for securely capturing, storing, inquiring andprinting electronic records and electronic signatures (ERES) in compliance with governmentregulations viz., the United States Food and Drug Administrations 21 CFR Part 11. Oracle E-Records is part of the Oracle E-Business Suite. In compliance with the United States Food andDrug Administration's (FDA) regulation on Electronic Records and Electronic Signatures 21CFR Part 11, critical business events in Oracle Discrete Manufacturing were enabled forElectronic Records and Electronic Signatures (ERES) in Release 11.5.10. Identification of thebusiness events to be enabled for ERES was based on the predicate GMP rule for MedicalDevice Manufacturers 21 CFR Part 820. A total of 55 business events across the modules inDiscrete Manufacturing have been enabled for ERES. The Discrete Manufacturing Products, thebusiness events for which have been enabled for ERES include - Inventory, Bill of Materials,

Engineering, Work in Process, Quality, Purchasing and Shipping. In this paper we deal with step-by-step details of setting up ERES for business events selected from the above products.Demonstrations have also been incorporated on the iSignatures feature introduced in Release11.5.10. iSignatures is in compliance with FDAs 21 CFR Part 11 and enables users to uploadany type of file to the database and to rout it for approval using the ERES framework.

SCOPE

This paper is intended for an audience familiar with Oracle Discrete Manufacturing product cyclesand seeking an insight into how the Electronic Records and Electronic Signatures (ERES)framework is built to cover important business events or transactions from each product cycle.This paper is functional in nature keeping in sight Oracles existing literature that has adequatedetails on the technical aspect of the ERES Framework and also the fact that the technicalframework for ERES remains the same for Oracles Process as well as Discrete ManufacturingSuites. This paper adheres to the content and borrows from the structure outlined in theReference texts listed under the Referencessection at the end of this paper. This document isintended to be supplementary in nature and does not in any way, purport to be a substitute forany official literature being drafted or currently published.

Due to the paucity of time business events from Purchasing and Shipping have not been covered in this paper only select business events from each of the Discrete Manufacturing Products (excluding

Purchasing and Shipping) have been included for our demonstrations.


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To prevent this document from becoming needlessly bulky with content already available (and notspecific to Discrete Manufacturing but applicable to Process Manufacturing as well), we havechosen not to elaborate on features introduced in Release 11.5.10 such as:

Delegate Signing Responsibility Signer List Modification

Enhanced Print Control Integration with XML Publisher

ABOUT THE FDAS 21 CFR PART 11

On August 20, 1997, the United States Food and Drug Administration (FDA) enacted Part 11 ofTitle 21 of the Code of Federal Regulations (21 CFR Part 11). 21 CFR Part 11 represents thecombined effort of divisions within the FDA, along with members of the pharmaceutical industry,to establish a uniform, enforceable, baseline standard by which the FDA will consider electronicrecords equivalent to paper records and electronic signatures equivalent to traditional handwrittenrecords and signatures. The regulation provides a uniform, enforceable, baseline standard foraccepting electronic records and their associated signatures and provides a level of confidencethat electronic records maintained in accordance with the rule will be of high integrity.

Where Part 11 describes the technical, administrative and procedural requirements for electronicrecordkeeping, one must look to the areas of the FDA code of federal regulations to determinewherethe requirements in Part 11 must be applied. These other areas are generally called theGxPs, which is a catch-all for good practices including Good Manufacturing Practices (GMP),Good Laboratory Practices (GLP), Good Clinical Practices (GCP), etc. The GxPs are also brokendown by regulated industry. For example, Parts 210 and 211 contain the GMPs forpharmaceuticals and Part 820 for medical devices. Oracle looks to these regulations as the basisfor designing the compliance solutions it offers its customers.

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In 2003, the FDA announced that it was re-examining 21 CFR Part 11 and would be taking amore narrow interpretation of the scope of part 11; focusing its efforts on assuring compliance forhigh-risk records. High-risk records are those whose integrity, or lack thereof, pose the greatestpotential risks to product quality and consequently, public health and safety. During the re-

examination period, the agency would be exercising enforcement discretion to certain part 11requirements, however the technical requirements outlined in the regulation remain in effect. So,the importance of record security, audit trails, operational system checks and electronicsignatures remain undiminished, however, the FDA will be looking for these requirements to bein-place in a more focused set of (high-risk) records. The FDA reaffirmed that 21 CFR Part 11 ishere to stay and it wants to encourage industry to embrace electronic recordkeeping because ofits significant potential benefits to the agency, industry and the public.

The Oracle E-Business Suite 11i provides a complete set of tools for managing electronicrecords, in accordance with the technical requirements in 21 CFR Part 11, including strongsecurity, audit trails, archiving, operational system checks built into GxP-critical business flowsand electronic signatures.

E-RECORDS AND E-SIGNATURES ON ORACLE TECHNOLOGY

1The approach Oracle has taken in delivering a flexible and usable solution is to take a frameworkapproach built on proven Oracle technology comprising:

Oracle Approval Management to configure approval rulesOracle Workflow to electronically route electronic signature requestsOracle XML Gateway to define the data content of e-recordsOracle Database to manage both the source transactional data, as well as the electronic recordsEvidence Store.


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that approvals are obtained almost instantaneously. This translates into quicker and cheaperproduct development, manufacturing and quality assurance turnaround.

Better Collaboration

Thephysicalityof paper records imposes the restriction that they can be accessed at any giventime only at the location where they are stored. As opposed to this, in an integrated globalenvironment, individuals with the requisite access privileges can view the electronic records andsign them without geographical location being a cause of concern. This facilitates faster decision-making.

Enforced Best Practices

Rigorous manual scrutiny is probably the only means to ensure that valid data in entered onpaper documents. Beyond the ability to manage vast amounts of data, computer systems,however, are adept at reducing data errors by providing users with lists of appropriate values tochoose from and validating data format prior to accepting or saving the data into files or tables.Oracle E-Records enables you to enter critical manufacturing, inventory and product qualityinformation directly into the system, because the controls that require signatures at critical pointsin your processes are built into the system and are configurable. This enables you to enforce

compliance with GxP and avoid reentry of data, which introduces data error risk.

Advanced Search and Analysis

Information on paper is static and standalone. Analysis to find trends across a multitude of paperrecords is tedious, time consuming and complex. Analysis across a large set of records may beimpossible. Enterprise systems that run on advanced relational database management systemsexcel at searching data records for the purpose of finding trends and patterns across largenumbers of records. Oracle E-Records offers a powerful E-Record query tool, to search youentire E-Record repository quickly and accurately, based on a wide variety of standard andconfigurable query criteria.

THE RESPONSIBILITIES REQUIRED FOR IMPLEMENTING E-RECORDS AND E-

SIGNATURES IN DISCRETE MANUFACTURING

The Responsibilities we would need for implementing ERES in Discrete Manufacturing are:1. Workflow Administrator Web Applications for enabling business events and their

subscriptions. To enable (or disable) business events and subscriptions, thisresponsibility needs to be accessed using the sysadmin login.

2. Approvals Management Administrator for defining Approval Groups, Conditions andRules.

3. Workflow or Workflow User Web Applications for accessing Notifications andresponding to them.

4. ERES Administrator for defining the Input Configuration Variables5. ERES Userfor accessing the E-Records from the Evidence Store.6. A Manufacturing Function Responsibility such as Manufacturing and Distribution

Manager, for accessing all the relevant Discrete Manufacturing Menu options.7. System Administratorfor setting the required EDR profile options at the Site level.

Note: The E-Records upon creation are stored in a repository called the Evidence Store. TheEvidence Store can be accessed either from the transaction windows or by using the ERES UserResponsibility.


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SETTING UP E-RECORDS AND E-SIGNATURES: A CASE FROM ORACLE PROCESSMANUFACTURING (OPM)

Before we review the components that constitute the ERES framework in Oracle Applications, itwould be worthwhile to study the setting up and implementation of ERES in a typical OPMbusiness event. This preliminary exercise would serve to introduce us to a live example thatwould subsequently ease the task of understanding the role that each stack of technology playsin operating the ERES framework.

Demo 00-A: The case of implementing E-Records and E-Signatures for OPM inventoryitems that have an Inventory Type of TEA or RAW

Case Summary

We define items in OPM Item Master such that an Inventory Type classifies each item. We havea pre-defined list of Inventory Types that have been defined in OPM Inventory Setup. Two ofthese types are TEA and RAW. Our objective is to ensure that the moment we create and try tosave an item in OPM Item Master with either of these two inventory types, the ERES frameworkwould trigger an E-Signature process, which would invite signatures from a pre-defined group offive approvers. These approvers are defined as employees in Oracle HRMS, and approval by all

five of them would be necessary before the item data entered in the Item Master form getscommitted to the database.

Demo 00-A Step 1: Defining our Approval Group

Fig 1. Approval Group to be used in all our ERES Business Events Setup in this paper

Approvals Management Administrator > Approvals


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Click on the Groupstab.Click on the button Add Group.

Refer the Demo Defining the PRB Approval Groupin Note 336709.1, for a step-by-stepreview

The five individuals constituting the group are defined as employees in Oracle HRMS.The Voting Regimefor this Approval Group has been defined a Serial, which implies that theorder, in which the members were added to the group (which in turn constitutes their serialnumber) is the same as the order in which the E-Record would be presented for signing when anapproval is sought on the transaction.

Note:In all the business events covered in this paper, to preserve some uniformity, the initialrequester would always be Member 1 i.e., Saumit Mandal. It intuitively follows that Members 2, 3, stand in an ascending order as per the position held by each in the organizations hierarchy.Thus, Ray Satyajit is the most senior member in the group and would be presented with the taskof signing the E-Record only after the same has been signed and approved by all the other

members.

Demo 00-A Step 2: Enabling our Business Event

Use the sysadmin login.Workflow Administrator Web Applications > Find Events/Event Group

The business event we are concerned with is termed oracle.apps.gmi.item.create.The Display Name is GMI ERES Item Creation.

Fig 2. Enabling ERES for Item Creation in Oracle Process Manufacturing

Note:Business events for ERES, can only be enabled using the sysadminlogin.

The Self Service Application opens a search page for Events.Search for the event with the Display NameGMI ERES Item Creation.Click on the Updateicon to set the status of the business event to Enabled in the UpdateEvents page.Return to the main events page and then click on the Subscriptionicon to set the status of theSubscription to Enabledin the Update Event Subscriptionspage.

Note:An event's Subscriptionis the integration point with ERES and the calling application.When the application raises an event, Subscriptions are invoked by workflow. ERES Subscription(when invoked) takes the snapshot of the transaction (E-Record) and proceeds for taking signersresponses based on the setup.

We have enabled our business event.Now, log out of sysadmin.


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Refer the Demo 00-A GMI ERES Item Creationin Note 336709.1 for a step-by-stepreview

Demo 00-A Step 3: Defining our Attribute

I now log in as the user SAUMIT.Using the Responsibility Approvals Management Administratornavigate to Approvals.Set the Transaction Typeas GMI ERES Item Creation.Now, click on the Attributestab.In the list of seeded Attributesavailable for Item Creation in OPM Inventory, we do not find an

Attribute that distinguishes items based on their Inventory Type. We have to define one.We define an Attribute with the name INVENTORY_TYPE. This Attribute will have values of typestring.

This Attribute is expected to pick up the Inventory Type of an item when it is being defined inOPM Inventory. This Inventory Type value would then be matched to a Condition embedded in aRule that we would subsequently define for GMI ERES Item Creation. To meet this requirement,

we define our Attribute Usageas dynamic, and define a Usagecontaining the SQL query thatwould pick the inventory type every time we define an item in OPM (Fig 3).

Fig 3. Defining an Attribute to trigger ERES for OPM items based on their Inventory Type

Demo 00-A Step 4: Defining our Condition using the Attribute defined in Step 3

Click on the Conditionstab. Click on the button Add a Condition. The Condition Typeis set as

ordinary. Now, select the AttributeINVENTORY_TYPE from the drop down list. One-by-one,enter two stringvalues for INVENTORY_TYPE viz., RAW and TEA (Fig 4).


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Fig 4. Defining values for the Attribute in creating our Condition

Demo 00-A Step 5: Defining our Rule using the Condition defined in Step 4

Click on the Rules tab. Click on the Add Rule and Usagebutton. The system generates a RuleKey. Select Action Typeas chain of authority includes an approval group. Select the PRBApproval Groupas the group that would be presented with the E-Signature process.

Fig 5. Defining our Rule for OPM Items having Inventory Type as RAW or TEA

Select the Condition we had defined in Step 4. The Rule has been defined (Fig 5).

Demo 00-A Step 6: Defining Input Configuration Variables for our newly created Rule

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Oracle continues to add support for electronic record keeping throughout the Oracle E-BusinessSuite. In addition to providing control at the transaction level, the same controls have been addedat the setup of the system. The user can now enable electronic record keeping on the Oracle E-Records Input Configuration Variables. This is a key control point in enabling or disablingelectronic record keeping on individual transactions. It is the setting of these variables, whichdetermine if electronic record keeping and electronic signature control is enabled at the

transaction level and optionally at the transaction rules level. Additional settings control whichstylesheet files and versions are used to format each electronic record.

Responsibility: ERES Administrator.Administration Tasks > Setup.Select Transaction Nameas GMI ERES Item Creation. There is only one Rule defined underthis business event, the one we have defined in Step 5. Select the same. Click on the button Go.


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Fig 6. Message indicating that Configuration Variables need to be defined for the Rule

We get the message as shown in Fig 6. We need to define the Configuration Variables for theRule Approval for Items in Tea Production. There are four seeded variables (Fig. 7).

Fig 7. Seeded Variables that determine the configuration of the E-record transaction

EREC_REQUIRED implies whether E-Records need to be maintained for the transaction.ESIG_REQUIRED implies whether E-Signatures are required with the E-Record.gmiitmxs.xsl is the seeded XML Stylesheet designed to capture into an E-Record, the datagenerated by the creation of an item in OPM Inventory. All business events that are seeded andsupported for electronic record keeping have pre-defined, seeded XML stylesheets against thevariable EREC_STYLE_SHEET. The seeded stylesheets can be replaced by custom definedstylesheets should there be a requirement to capture additional information. Oracle XMLPublisher Users Guide Release 11i, details how to design stylesheets. Finally,EREC_STYLE_SHEET_VER specifies the version of the stylesheet in use. The default values ofeach of these variables are user-updateable.

As Fig 7 shows, we specify E-Record required and E-Signature required asY(or Yes) for ItemCreation in OPM.

The setup required for triggering the creation of E-Records and E-Signatures in OPM ItemCreation, is complete. Now, select Responsibility OPM Inventory and navigate toOPM Inventory Control > Setup > Item Master.


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supported for those events where the signers are likely to be separated geographically and/or thesigners require time to review the information captured in the E-Record before taking a decision.

The List Of Signerspage (Fig 9) always indicates whether Deferred Signature is allowed for thegiven transaction or event.

GMI ERES Item Creation is a business event, which is seeded to accommodate DeferredSignature as well. This implies that if all the signers are not present at the same location, therequester Saumit Mandal may choose to approve the item and then submit the rest of the signingprocess for the other signers to pick up. In that case, the next approver Andre Wajda wouldreceive a workflow notification indicating that an item approval is pending. Andre Wajda wouldthen approve the item and endorse his approval with his E-Signature, by entering his applicationslogin and password. A workflow notification would then go to the third approver Jean Renoir, andthe process continues till the last approver Ray Satyajit validates the transaction with his E-Signature. In the demo 00-A GMI ERES Item Creation, we use Deferred Signature for obtainingthe E-Signature of each approver after receiving the approval and signature of the initialrequester Saumit Mandal.

Once all the approvers have approved the new item and endorsed the same with their electronicsignatures, the E-Record assumes the form as shown in Fig 10.


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Fig 10. The Completed E-Record for item creation in Oracle Process Manufacturing

Refer the Demo 00-A GMI ERES Item Creationin Note 336709.1 for a step-by-step

review


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Demo 00-B: The case of implementing E-Records and E-Signatures for OPM inventoryitems that have a specific suffix in the item name

Case Summary

Continuing the example taken in Demo 00-A, we now have items with item names spanning 22characters. The last 5 characters from an item name determine whether the item is a processedas a Leaf, Dust or Fiber. These examples are taken from the Tea Processing industry that wasdealt with in the white paper in Note 296558.1(published on the Metalink).

Demo 00-B Step 1:We would be using the same Approval Group PRB Approval Group as wasdefined in Demo 00-A Step 1.

Demo 00-B Step 2:The business event GMI ERES Item Creation has already been enabled inDemo 00-A Step 2.

Demo 00-B Step 3: Defining our Attribute

This time we define our Attribute as dynamic, with a SQL query that picks up the item name

between the 18thand the 22ndcharacters i.e. the last five characters (Fig 11).

Fig 11. Defining our dynamic Attribute that picks up the last 5 characters in the item name

The Attribute we have defined is called COMPONENT_TYPE. The last 5 characters in the namewould specify whether the item is a Leaf, Dust or Granule. We therefore need to create aCondition to meet this requirement.

Demo 00-B Step 4: Defining our Condition using the Attribute defined in Step 3

We define the Test Values TDUST, GRANL and FIBER as the Attribute Values that must existin the item name for the Condition to be satisfied (Fig 12).


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Fig 12. Defining values for the Attribute in creating our Condition

Demo 00-B Step 5: Defining our Rule using the Condition defined in Step 4

The Rule we define (Fig 13) requires the approval process to be routed through the PRBApproval Group and incorporates the Condition that the COMPONENT_TYPE Attribute would

have any of the three values defined in Fig 12.

Fig 13. Defining our Rule for OPM Items having a suffix of FIBER, GRANL or TDUST in theitem name

Note:We now have two Rules for the event GMI ERES Item Creation (Fig 14).

Fig 14. The two Rules defined so far for GMI ERES Item Creation

Demo 00-B Step 6: Defining Input Configuration Variables for our newly created Rule

Select Responsibility ERES Administrator.


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Navigate to Administration Tasks > Setup.Select Transaction Nameas GMI ERES Item Creation. There is only one Rule defined underthis business event, the one we have defined in Step 5. Select the same. Click on the button Go.

Fig 15. Message indicating that Configuration Variables need to be defined for the Rule

We define the same values for the Rule Variables as shown in Fig 7. We specify that both E-Records and E-Signatures are required for this Transaction and Rule combination.

Responsibility: OPM InventoryOPM Inventory Control > Setup > Item Master

We now define an item GRADE-1 TEA LEAF_GRANL in the Item Master form in OPM Inventory.Of the 22 characters in the item name the last 5 characters have the string value GRANL, whichsatisfies the Rule Approval for Tea Leaf Components(Fig 13). Upon saving the item andselecting the Approve New Itemoption from the Actions menu, we are presented with the list ofapprovers as shown in Fig 9.

This time we do not use the Deferred Signature process. Assuming all signers are present at thesame place at the same time, we use the online approval mode.

Refer the Demo 00-B GMI ERES Item Creationin Note 336709.1 for a step-by-stepreview

USING THE 00-A, 00-B DEMO SET TO UNDERSTAND AME FUNDAMENTALS APPLICABLETO ERES

8Oracle Approvals Management (AME) is a selfservice web application that enables users to

define business rules governing the process for approving transactions in other OracleApplications. Rules are constructed from conditions and approvals.

Transaction Attributes

In AME, an attribute is a named business variable such as TRANSACTION_AMOUNT, whosevalue AME fetches at run time. AME includes the attributes commonly required for the transactiontypes of each application that can use AME. However, there may be occasions when an attributewould need to be defined to suit a specific requirement. The attributes INVENTORY_TYPE andCOMPONENT_TYPE that we defined in Demo 00-A and Demo 00-B respectively are examples


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of user-defined attributes. Only a user with the Approval Management Administrator responsibilitycan create or alter attributes (using the Attributestab), because doing so generally requiresentering or changing an SQL query.

For setting up ERES in Discrete Manufacturing modules as detailed in the demonstrations thatfollow, we shall use the seeded attributes available in AME under the given business events orTransaction Types.

Static and Dynamic Attribute Usages

A static usage specifies a fixed value for the attribute, for all items and transactions. A staticusage always stores an attribute value as a string, regardless of the attribute's data type. Thestring form of the attribute value should not exceed 100 bytes. Static usages should not use eithersingle or double quote marks to demarcate strings.

It is common practice to give static usages to most or all of the mandatory attributes. One reasonis that static usages require less runtime overhead than dynamic usages. Another is that staticusages express uniform business policies for all transactions in a given transaction type. Fig 16 isan example of an attribute with static usage that we have defined for demonstrating theiSignatures feature.

Fig 16. Example of an Attribute with Static Usage

8A Dynamic Usage specifies an SQL query that AME executes at run time to fetch the Attribute'svalue for each item in the Attribute's item class, for a given transaction. Dynamic usages can beup to 4000 bytes long. They should not end with a semicolon. A dynamic usage can reference atransaction's ID by using the bind variable ':transactionId'. The transaction-ID placeholder is atrue dynamic PL/SQL bind variable. That is, at run time, AME binds a transaction-ID value to thisvariable before dynamically executing the query. A condition of a where clause referencing thisbind variable must have the form:

transaction ID = :transactionIdwhere transaction ID is a column that contains the transaction ID passed to AME at run time bythe application whose transaction type uses the query.

The query we used for attribute INVENTORY_TYPE in Demo 00-A

select inv_typefrom ic_item_mst_bwhere item_id = :transactionId


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was based on the same principles. So too with the query for Attribute COMPONENT_TYPEdefined in Demo 00-B.

Conditions

In AME, a Condition specifies a list or range of Attribute values required to make a Rule apply toa transaction. For example:COMPONENT_TYPE in {FIBER,GRANL,TDUST}

There are three types of Conditions: Ordinary Exception List-modification

In this paper we shall be using Ordinary Conditions to activate ERES for all our business events.

A Note on Ordinary Conditions

An Ordinary Condition associates an Attribute with a set of allowed values or range. Such aCondition is true when the Attribute has one of the allowed values. We then say that the

Attribute's value satisfies the Condition. Ordinary Conditions have one of three forms.

Conditions on Date, Number, and Currency Attributes

These Conditions are associated with an approver type and have the formattribute_name = approver_nameThat is, the Condition is true when the Attribute's value is the ID of a specified approver of thetype associated with the Attribute.

Conditions on date and currency attributes, and number Attributes not associated with anapprover type, have the form,lower_limit


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Implementing E-Records and E-Signatures for Discrete Manufacturing

Now, that we have a working knowledge of AME fundamentals, we set our sights on setting upERES in individual applications in Discrete Manufacturing.

The steps to implementing ERES are:

1. Enable EDR Profile Options2. Enable Workflow Business Event and Event Subscription3. Approvals Management (AME) Setup

- Approval Group- Attribute- Condition- Rules

4. ERES Configuration Variables- Setting E-Record and E-Signature flags- Specifying stylesheet name and version

Enabling EDR Profile Options

EDR: E-Records and E-Signatures. To enable the ERES functionality for the entire system, thisprofile option must be set toYesat the Site level.

Note:Some applications have additional profile settings to facilitate ERES for business eventsassociated with those applications. Demo 00-A and 00-B were executed in OPM Inventory orGMI. To activate ERES in GMI, the profile option GMI: E-Signature Activemust also be set to

Yes at the Site level, over and above the profile EDR: E-Records and E-Signatures. If theprofile GMI: E-Signature Activeis not set to Yes, the Approve New Items option would notappear in the Actions menu (Fig 8). However, the Discrete Manufacturing applications ofInventory, Bill of Materials, Engineering, Work In Process and Quality do not have any

application-specific profile options for enabling ERES.

EDR: Server Time zone. Set this profile option to the time zone where the database is running.

EDR: Workflow Notification Timeout Interval. This profile option determines the number oftimes you receive an e-mail notification reminder. It works in conjunction with the EDR: WorkflowNotification Timeout (in Hours)profile option. This is set at the Site level only.

EDR: Workflow Notification Timeout (in Hours). This profile option determines the length oftime between reminder notifications. It works in conjunction with the EDR: Workflow NotificationTimeout Interval profile option. This is set at the Site level only.

EDR: E-record Print Granted. This profile lets the administrator restrict access to printing E-Records. The default value, No, set at the Application level restricts everyone in that applicationfrom printing E-Records. The system administrator can set the profile option toYesfor specificusers to grant printing capabilities.

Enabling Workflow Business Event and Event Subscription

This shall be done when we deal with individual business events in each application.


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Approvals Management (AME) Setup

This shall be done when we deal with individual business events in each application.

ERES Configuration Variables

This shall be done when we deal with individual business events in each application

E-RECORDS AND E-SIGNATURES IN ORACLE INVENTORY

There are five business events concerning Inventory Items that are seeded and supported forERES.

Fig 17. Business Events in Oracle Inventory Items that are seeded and supported for ERES

Of these, we shall deal with the following three:

INV ERES Item CreationINV ERES Item UpdateINV ERES Item Revision Entry

There are six business events concerning Inventory Transactions that are seeded and supportedfor ERES.

and

Fig 18. Business Events in Oracle Inventory Transactions that are seeded and supportedfor ERES

Of these (Fig 18), we shall deal with INV ERES Miscellaneous Receipt, as setting up ERES forthe other Inventory Transaction business events would involve the same steps.

But before we proceed, we need to ensure that the business events are enabled and so are theirsubscriptions.


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Refer the Demo 011 INV ERES Item Creation inNote 336709.1 for a step-by-stepreview

INV ERES Item Creation

Approvals Management Administrator > ApprovalsSelect the Transaction TypeINV ERES Item Creation.Click on the Attributestab.Select the seeded Attribute ORGANIZATION_CODE.This is an Attribute with a Dynamic Usage defined by the SQL:

select organization_codefrom mtl_parameterswhere organization_id = to_number(substrb(:transactionId,1,instrb(:transactionId,'-') -1))

Under the Conditionstab, we had defined the following ConditionORGANIZATION_CODE in {M1,M2,M3}when setting up ERES for the event Bill of Materials Creation (to be discussed in the next

section). We shall use this Condition for our business events in Oracle Inventory with themodification that the Condition will include the organization V1 as well. So the Condition nowbecomes:ORGANIZATION_CODE in {M1,M2,M3,V1}.

Under the Rulestab, we define a Rule: INV Item Creation in V1, M1, M2 and M3

Note:When defining a Rule in AME, we shall be using the Action Type chain of authorityincludes an approval groupthroughout this paper. This will enable us to use the PRBApproval Groupthat we had defined in Demo 00-A Step 1 (Fig 1).

We thus come up with the Rule in Fig 19.

Fig 19. The Rule for Creating Items in Oracle Inventory in the ERES Framework

To define the Input Configuration Variables for this Transaction Type, useERES Administrator > SetupFor Transaction Type= INV ERES Item Creation


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and Rule= INV Item Creation in V1, M1, M2 and M3, we set EREC_REQUIRED = Y andESIG_REQUIRED = N.Thus Item Creation will generate an E-Record but will not call for E-Signatures.

Responsibility: Manufacturing and Distribution ManagerInventory > Items > Master ItemsWe now define an item (STJ180/15) in Item Master organization V1 and save it.Upon navigating to Tools > eRecord Details, we are led to the Evidence Store where the followingE-Record is available:

Fig 20. The E-Record for item STJ180/15 created in organization V1

Click on the link under Event Nameto open the E-Record. The E-Record header provides detailsof the user who created the record (Requester), the Event Name and the t ime stamp (Fig 21).


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Fig 21. The E-Record for Item Creation in Oracle Inventory

Refer the Demo 011 INV ERES Item Creation in Note 336709.1 for a step-by-stepreview

INV ERES Item Update

Here, we use the same Attribute and Condition as was used in Item Creation. The structure of theRule too remains the same (composed of the same Attribute and Condition). Only this time, theRule has a different name: INV Item Update in V1, M1, M2 and M3.

The Rule Variables are again set as EREC_REQUIRED = Y and ESIG_REQUIRED = N.

The item we created in V1 (STJ180/15) has been assigned to M1, M2 and M3.We now navigate to Organization Items and select the organization M2.

Responsibility: Manufacturing and Distribution ManagerInventory > Items > Organization Items

We query for the item STJ180/15. When the item is retrieved, we change the items SerialGeneration from At Receiptto At Sales Order Issue. We save our work.

We navigate to Tools > eRecord Details to locate the resulting E-Record in the Evidence Store(Fig 22).

Fig 22. The E-Record for item STJ180/15 updated in organization M2

Click on the link under Event Name to open the E-Record. The E-Record for Item Update wouldhave the same structure as that for Item Creation since in both events, the seeded stylesheet

used (inviditm.xsl) is the same.

Refer the Demo 012 INV ERES Item Update inNote 336709.1 for a step-by-step review

INV ERES Item Revision Entry


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Here, we use the same Attribute and Condition as was used in Item Creation and Item Update.The structure of the Rule too remains the same (composed of the same Attribute and Condition).However, the Rule has a different name: INV Item Revision Entry in V1, M1, M2 and M3.

ERES Administrator > Setup

This time the Rule Variables have been set as EREC_REQUIRED = Y and ESIG_REQUIRED =Y. We would need E-Signatures to complete the transaction.

We now navigate to the Master Items form in Oracle Inventory and query for the item STJ180/15in Item Master organization V1.

Responsibility: Manufacturing and Distribution ManagerInventory > Items > Master ItemsClick on the Revisionstab at the top left corner.

Fig 23. Creating a New Revision for item STJ180/5

As soon as we save the new revision entry (Fig 23), the List Of Signerspage is launched (Fig24).

Fig 24. The approvers whose E-Signatures would be required to commit the new revisionentry


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As Fig 24 shows, Deferred Signature is not available for this business event. The approvers haveto validate the transaction with their E-Signatures in Online mode, which implies that the signersmust sign the E-Record then and there.

Fig 25. The E-Record for Item Revision Entry

Fig 25 shows the signature details as evidenced on the E-Record, after all the signers haveapproved the transaction.


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Refer the Demo 013 INV ERES Item Revision Entry inNote 336709.1 for a step-by-stepreview

INV ERES Miscellaneous Receipt

Approvals Management > ApprovalsSelect the Transaction TypeINV ERES Miscellaneous Receipt.Click on the Attributestab.Select the seeded Attribute ORGANIZATION_CODE.This is an Attribute with a Dynamic Usage defined by the SQL:

select organization_codefrom mtl_eres_transactions_gtmpwhere original_transaction_temp_id =to_number(:transactionid)

The table mtl_eres_transactions_gtmpis a new global session table introduced into OracleInventory through 11i.SCM_PF.J. This table holds Inventory Transactions (Misc UI headerinformation) for electronic record capture purposes. The current session is able see data that itplaced in the table but other sessions cannot. Data in the table is temporary. It has a dataduration of SYS$TRANSACTION. Data is removed at the end of this period.

Note:The DURATION column in dba_tablesor user_tablesor all_tablescan have avalue of SYS$SESSIONor SYS$TRANSACTION. These values indicate the duration of atemporary table. SYS$SESSIONimplies the rows are preserved for the duration of the sessionwhile SYS$TRANSACTIONindicates that the rows are deleted after COMMIT.

The Conditionthat we had defined under INV ERES Item Creation viz., ORGANIZATION_CODEin {M1,M2,M3,V1} is available under the Conditionstab and we use the same in defining ourRule INV Misc Receipt in M1, M2 and M3 (Fig 26).

Fig 26. The Rule for performing a Miscellaneous Receipt in the ERES Framework


The Rule Variables have been set up as EREC_REQUIRED = Y and ESIG_REQUIRED = Y.We are calling for E-Signatures from our five approvers to ratify a Miscellaneous ReceiptTransaction.


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Inventory > Transactions > Miscellaneous Transactions

Select organization M3.Perform a Miscellaneous Receipt of 50 units of the item SRCJ200/20 into the Storessubinventory. Item SRCJ200/20 would be introduced in the section where we implement ERES inOracle Quality. Upon saving the transaction, the List Of Signersweb page opens up.

Once each approver has approved the transaction and validated the same with electronicsignatures, navigate to the Evidence Store using the ERES User responsibility.

ERES User > Evidence Store

Fig 27. The E-Record for Miscellaneous Receipt in the Evidence Store

The E-Record for Miscellaneous Receipt is available in the Evidence Store (Fig 27).

The E-Record opens up as shown in Fig 28.


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Fig 28. The E-Record for Miscellaneous Receipt

Refer the Demo 014 INV ERES Miscellaneous Receipt inNote 336709.1 for a step-by-step review

E-RECORDS AND E-SIGNATURES IN ORACLE BILL OF MATERIALS

There are four business events that are seeded and supported for ERES.

Fig 29. Business Events in Oracle Bill of Materials that are seeded and supported for ERES

We shall demonstrate implementation of ERES with each of these four business events.

BOM Bill of Materials Create

Using sysadmin login, ensure that the business event and its subscription are enabled.

Approvals Management Administrator > ApprovalsSelect the Transaction TypeBOM ERES Bill of Materials Creation.Click on the Attributestab.Select the seeded Attribute ORGANIZATION_CODE.This is an Attribute with a Dynamic Usage defined by the SQL:

select organization_codeFROM mtl_parameterswhere organization_id = (select organization_id

from BOM_BILL_OF_MATERIALSWHERE bill_sequence_id = TO_NUMBER(:transactionId))

Under the Conditionstab, we define a new Condition:ORGANIZATION_CODE in {M1,M2,M3}For the business events in Inventory, we had modified this to include V1 as well.


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Under the Rulestab, we define the Rule shown in Fig 30.

Fig 30. The Rule for the BOM Creation Event

ERES Administrator > SetupFor Transaction Name= BOM ERES Bill of Materials Creationand Rule= BOM Creation in M1, M2 and M3, we set EREC_REQUIRED = Y andESIG_REQUIRED = N.Thus BOM Creation will generate an E-Record but will not call for E-Signatures.

We now navigate to the Bill of Materials creation form, select M1 as our organization and define aBOM for the item Humidifier.

Responsibility; Manufacturing and Distribution ManagerBills Of Materials > Bills > Bills

Having defined the BOM and upon saving our work, we navigate to Bills > eRecord Details toreview the E-Record created (Fig 31).

We are now led to the Evidence Store where the E-Record for BOM Creation is available (Fig32). Clicking on the link below the Event Name, will open the E-Record.

The complete E-Record is shown in Fig 33.


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Fig 31. Accessing the E-Record for the Bill of Material created

Fig 32. The newly created E-Record in the Evidence Store


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Fig 33. The E-Record for Bill of Material Creation

We now change our organization to M3. Since the item Humidifier is assigned to M3 as well, wecopy the BOM of the Humidifier from M1 to M3, using Tools > Copy Bill from. We now add anattachment to this BOM using the paper clip Attachments icon on the menu bar. We save theBOM.

Navigate to Bill > eRecord Details as shown in Fig 31. Open the E-Record from the evidenceStore.


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Fig 34. E-Record Header for a Bill of Material with an Attachment

The E-Record opens with the Attachment we had uploaded onto the BOM, when creating thesame in M3 (Fig 34).

Note:The Attachment utility in Oracle E-Records is used to attach business entities,documents, spreadsheets, images or videos to an E-Record. It is configurable by documentcategory and it is set up in the XML map. Essentially, this allows the developers of Oracle E-Record events to include attachments of specified document categories as part of the E-Recordapproval process and to be saved with the E-Record once all the approvals have been obtained.

Attachments have not been enabled for all of the seeded, supported E-Record events in OracleApplications at this point. However, all the four business events in Fig 29, support Attachmentsfor their E-Records.

Refer the Demo 021 BOM ERES Bill of Materials Create inNote 336709.1 for a step-by-step review

BOM Bill of Materials Update



Here, we use the same Attribute and Condition as was used in BOM Creation. The structure ofthe Rule too remains the same (composed of the same Attribute and Condition). Only this time,the Rule has a different name: Bill Updation in M1, M2 and M3.


The Rule Variables are again set as EREC_REQUIRED = Y and ESIG_REQUIRED = N.

We now navigate to the Bill of Materials Creation form in organization M1, and query for the BOMof Humidifier. We change the Quantityof Heating Coils from 4 to 5. We save our work ant thennavigate to Bills > eRecord Details.

Fig 35. The E-Record in the Evidence Store

The E-Record for Bill of Materials Update is available in the Evidence Store (Fig 35).


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Fig 36. E-Record for Bill of Materials Update

The E-Record body captures the new component quantity (Fig 36).

Refer the Demo 022 BOM ERES Bill of Materials Update in Note 336709.1 for a step-by-step review

BOM Routing Create


Approvals Management Administrator > ApprovalsSelect the Transaction TypeBOM ERES Operational Routing Creation.Click on the Rules tab.In a departure from our previous setup, we are simply going to reference the Rule we had createdfor BOM ERES Bill of Materials Creation. This implies that we will create a copy of the Rule forour current Transaction Type.

Under the Rulestab, click on the Add Usagebutton. In all our previous cases we had used theAdd Rule and Usagebutton. Next, select the option add usage for rule used by anothertransaction type. When prompted to select the Transaction Type, select BOM ERES Bill ofMaterials Creation from the drop down list. The Rule BOM Creation in M1, M2 and M3defaultssince it is the only rule defined for BOM Creation. The Rule is copied for the current TransactionType.


The Rule Variables are set as EREC_REQUIRED = Y and ESIG_REQUIRED = Y. We want

routing creation to be approved through E-Signatures.

Responsibility: Manufacturing and Distribution ManagerBills Of Materials > Routings > Routings

We navigate to the Routing Creation form and select organization M3. We define a singleoperation routing for the item SCJ180/20. Upon saving our work, we are presented with the ListOf Signerspage. This business event does not permit deferred signature. The signatures haveto be made in online mode. Once the signatures and the approval from the individual signers has


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been received, we navigate to Actions > eRecord Details. We find the E-Record in the EvidenceStore (Fig 37).

Fig 37. The E-Record for Routing Creation

Open the E-Record (Fig 38).


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Fig 38. E-Record for Routing Creation

Fig 39. The E-Record Signature Details

Refer the Demo 023 BOM ERES Operational Routing Creationin Note 336709.1 for astep-by-step review

BOM Routing Update


Approvals Management Administrator > ApprovalsSelect the Transaction TypeBOM ERES Operational Routing Update.Click on the Rules tab.

As in the case of BOM Routing Creation, we are simply going to reference the Rule we hadcreated for BOM ERES Bill of Materials Creation. The steps to be followed are the same asdescribed in BOM Routing Creation.


The Rule Variables have been set as EREC_REQUIRED = Y and ESIG_REQUIRED = Y.

Responsibility: Manufacturing and Distribution Manager


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Bills Of Materials > Routings > Routings

We navigate to the Routing Creation form in organization M3 and requery the routing forSTJ180/15. Here, we change the Usageof the Resource LATHE from 0.25 to 0.5. Upon savingour work, we are presented with the List Of Signerspage. This business event does not permitdeferred signature. The signatures have to be made in online mode. Once the signatures and theapproval from the individual signers has been received, we navigate to Actions > eRecordDetails. We find the E-Record in the Evidence Store (Fig 40).

Fig 40. The E-Record for Routing Updation

When we open the E-Record, we find the new Usage quantity captured in the E-Record (Fig 41).


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that a good design control program that documents the decisions made in the process would make it

difficult for a design error to propagate through the entire process.

Industry agreed with FDAs fundamental concept, but was concerned that if documentation were requiredtoo early in the process, the free flow of creative ideas could be diminished, thus stifling innovation. There

are clear benefits to the use of Design Control in an R&D setting that leads directly to manufacturing.

Nevertheless, one must keep focused on the ultimate goal, which is the development and production of a

commercially viable, safe product. The initial creativity of the designers and engineers is critical to the

success of such endeavors.

Ultimately, FDA settled on a compromise position that satisfied regulatory needs and also satisfied

industrys needs. Each company must define within its quality system the point at which Design Controlbecomes effective. This enabled the industry to set the entry point late enough that the design is beyond the

point of daily change, yet FDA was comfortable that the information needed to determine how the company

approached its design and the justification for major design decisions would be recorded.

Industry Coalition on 21 CFR Part 11

Docket 00D-1541, June 2002

There are ten business events that are seeded and supported for ERES in Engineering.

Fig 43. Business Events in Oracle Engineering that are seeded and supported for ERES

We shall demonstrate implementation of ERES with the following five business events:Copy To ManufacturingTransfer to ManufacturingECO CreationECO ScheduleECO Implementation

Transfer To Manufacturing


Approvals Management Administrator > ApprovalsSelect the Transaction TypeENG ERES Transfer To Manufacturing.Click on the Attributestab.Select the seeded Attribute ORGANIZATION_CODE.This is an Attribute with a Dynamic Usage defined by the SQL:


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select organization_codefrom eng_revised_items_tempwhere temp_id = :transactionId

The table eng_revised_items_tempis a global temporary table. The current session is able

see data that it placed in the table but other sessions cannot. Data in the table is temporary. Ithas a data duration of SYS$SESSION. Data is removed at the end of this period.

The Condition we had defined earlier under BOM and Inventory, exists under the Conditionstab,viz., ORGANIZATION_CODE in {M1,M2,M3,V1}.

Under the Rulestab, we define the Rule shown in Fig 44.

Fig 44. The Rule for the Engineering Transfer to Manufacturing Event


For Transaction Name= ENG ERES Transfer to Manufacturingand Rule= ENG Transfer to Mfg for Prototypes in V1, M1, M2 and M3, we set the Rule Variablesas EREC_REQUIRED = Y and ESIG_REQUIRED = Y.

Using the Manufacturing and Distribution Manager Responsibility, we now navigate toEngineering > Prototypes > Master ItemsSelect organization M3.In Item Master org V1, we define an item Universal Humidifier Pad.We assign this item to M1, M2 and M3.

Engineering > Prototypes > Transfer to Manufacturing

Enter the item Universal Humidifier Pad and click on the Transferbutton.

This opens the web page with the List Of Signers.

Deferred signature is not allowed in this event, all signatures have to be executed online.Once the E-Signature process is complete and the Transfer to Manufacturing has been approvedby all the signers, switch to the ERES User responsibility. This will open the Evidence Store.Search for E-Records with the Event NameTransfer To Manufacturing. Our E-Record isavailable in the Evidence Store (Fig 45).


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Fig 45. The E-Record available in the Evidence Store

Open the E-Record seen in Fig 45.

Fig 46. The E-Record for Transfer To Manufacturing

Refer the Demo 032 ENG ERES Transfer to Manufacturingin Note 336709.1 for a step-by-step review


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Copy To Manufacturing


Approvals Management Administrator > ApprovalsSelect the Transaction TypeENG ERES Copy to Manufacturing.Click on the Rules tab.Once again, we are simply going to reference the Rule we had created for ENG ERES Transferto Manufacturing. This implies that we will create a copy of the Rule for our current TransactionType.

Under the Rules tab, click on the Add Usagebutton (instead of the Add Rule and Usagebutton). Next, select the option add usage for rule used by another transaction type. Whenprompted to select the Transaction Type, select ENG ERES Transfer to Manufacturing from thedrop down list. The Rule ENG Transfer to Mfg for Prototypes in V1, M1, M2 and M3defaultssince it is the only rule defined for Engineering Transfer to Manufacturing. The Rule is copied forthe current Transaction Type.


The Rule Variables are set as EREC_REQUIRED = Y and ESIG_REQUIRED = Y. We want Copyto Manufacturing to be approved through E-Signatures.

Engineering > Prototypes > Items > Master ItemsUsing the Engineering Master Items form in organization V1, we create a new item, Water Tray.We assign this item to organizations M1, M2 and M3.

Engineering > Prototypes > Copy to ManufacturingSelect the organization as M3.

Fig 47. Copying item Water Tray to Manufacturing

Copy the item to Manufacturing as shown in Fig 47.The moment we click on the Copybutton, the List Of Signerspage is launched (Fig 48).


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After the signing process completes, and all the approvers approve the transaction, navigate tothe Evidence Store using the ERES User responsibility. There are three E-Records created as aresult of the Copy to Manufacturing transaction (Fig 49).

Fig 48. List of Signers configured to approve the Copy to Manufacturing Transaction

Fig 49. Three E-Records created as a result of the Copy to Manufacturing transaction

The first E-Record was created when we defined the item Water Tray in the EngineeringPrototypes Master Items form. This E-Record has the E-Record ID 28068 (Fig 49). This E-Recordwas created because we have the event INV ERES Item Creation enabled.

The second E-Record was created as a result of the actual Copy to Manufacturing transaction.This E-Record has the E-Record ID 28069 (Fig 49).

The third E-Record was created when the item Water Tray was copied into Manufacturing in M3organization under the name Standard Water Tray. This E-Record creation too was triggeredbecause the event INV ERES Item Creation is enabled.

When we open the E-Record for Copy To Manufacturing (Fig 50), we find the necessaryinformation encapsulated in the field Identifier Value. The field displays Water Tray-M3-Standard Water Tray, which implies that, the Engineering item Water Tray was copied intoorganization M3 under the name Standard Water Tray. Also, E-Record ID 28070 appears as theChild Record of the current E-Record.


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Fig 50. The E-Record for Copy to Manufacturing

Refer the Demo 031 ENG ERES Copy to Manufacturingin Note 336709.1 for a step-by-step review


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Engineering > Setup > Change Types > (B) ProcessesClick on the Processesbutton.In the Change Type Processeswindow that opens up, select from the LOV, the Priority21CFR11 that we had defined in the previous step. From the LOV, select the ProcessERES

Approval Process (Fig 53).

Fig 53. Associating the seeded Workflow ERES Approval Process to the Priority and theChange Type

Engineering > Setup > Approval ListsSince the business event ECO Approval does not use AME, we will not be able to use the

Approval Group that we had defined in AME in Demo 00-A Step 1 (Fig 1). We would thereforerecreate the same Approval Group as an Approval List in Engineering (Fig 54).

Fig 54. List of Approvers for ECO Approval

Refer the Demo 030 ENG ERES ECO Setup in Note 336709.1 for a step-by-step review

ECO Creation

Approvals Management Administrator > ApprovalsSelect the Transaction TypeENG ERES ECO Creation.Under the Attributestab we select the following three seeded Attributes:(i) PRIORITY. This is an Attribute with a Dynamic Usage defined by the SQL:

select priority_codefrom eng_engineering_changeswhere change_id = to_number(:transactionId)


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If we query the instance for priority codes (Fig 55), we find our Priority 21CFR11 available.

Fig 55. Querying the Priority Code we had defined previously

We shall use the PRIORITY Attribute to create a Condition in AME for ECO Creation.

(ii) ORGANIZATION_CODE. This is an Attribute with a Dynamic Usage defined by the SQL:

select organization_codefrom mtl_parameterswhere organization_id = (select organization_id

from eng_engineering_changeswhere change_id = to_number(:transactionId))

The Condition we had defined earlier under BOM and Inventory (using this Attribute), exists underthe Conditionstab: ORGANIZATION_CODE in {M1,M2,M3,V1}.

(iii) ECO TYPE. This is an Attribute with a Dynamic Usage defined by the SQL:

select ecotvl.type_namefrom eng_engineering_changes eec, eng_change_order_types_vl ecotvlwhere eec.change_id = to_number(:transactionId)and eec.change_order_type_id = ecotvl.change_order_type_id

If we modify this query slightly and use it to query the instance (Fig 56), we find the Change Typethat we had defined previously (Fig 52), as available.

We shall use the ECO TYPE Attribute to create a Condition in AME for ECO Creation.


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Fig 56. Querying the ECO Change Types available in our instance

Under the Conditionstab we create the conditions involving Attributes ECO TYPE andPRIORITY (Fig 57). The asterisk (*) associated with the Condition using ORGANIZATION_CODEdenotes that this Condition has been used by other Transaction Types in AME.

Fig 57. The Conditions to be used for our ECO related business events

Under the Rulestab, we define the Rule as shown in Fig 58.

Fig 58. The Rule for ECO Creation


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For Transaction Name= ENG ERES ECO Creation and Rule = ENG ECO Creation in V1, M1,M2 and M3, we set the Rule Variables as EREC_REQUIRED = Y and ESIG_REQUIRED = Y.


Responsibility: Manufacturing and Distribution ManagerEngineering > ECOs > ECOs

Select organization M3.We define ECO= SMECO30Select from the LOV, Type= 21 CFR Part 11Select from the LOV, Priority= 21CFR11Upon doing so, The Approval Listfield becomes mandatory, the Approval Processdefaults asERES Approval Process(seeded) and the Approval Statusfield defaults as Not submitted forapproval. This occurs because of the setup steps demonstrated in Fig 51, Fig 52 and Fig 53.

Select from the LOV, Approval List= PRB.

We enter the Descriptiondetailing what we wish to achieve through the ECO (Fig 59).

Fig 59. The Description explaining the purpose of creating this ECO

Now, click on the Revised Itemsbutton.This opens the Revised Itemsform.We enter Item= Humidifier and tab out.

Now click on the Componentsbutton.This opens the Revised Componentsscreen.In the Actionfield, we select Addfrom the LOV.We are going to add a component to our Bill for the Humidifier in organization M3.We add a component Standard Water Tray in Item Sequence 40 in the Bill for the Humidifier.Close the Revised Componentswindow and the Revised Itemswindow.We are back to the main ECO screen.We are going to attach some files to this ECO.In the toolbar menu, click on the paper clip icon meant for Attachments.We upload two files as attachments. One contains the diagram of the Humidifier and the othercontains a photograph of the Water Tray.Once the attachments have been successfully uploaded, we click on the Submitbutton.The List Of Signersweb page is launched with the Event Name asECO Creation.Deferred signature is not allowed in this event.

The approvers read the document and validate it with their E-Signatures one-by-one in onlinemode. The attachments are available on the E-Record being approved and signers can open andview the attachments before endorsing the document with their E-Signature.When approvals for all the five approvers have been obtained, the Approval Statusfield in theECO changes from Not submitted for approvalto Approval requested.

Navigate to Actions > eRecord Details from the toolbar menu. This leads us to the EvidenceStore.


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The E-Record for ECO Creation is visible in the Evidence Store (Fig 60).

Fig 60. The E-Record for ECO Creation in the Evidence Store

Fig 61 shows the complete E-Record.


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Fig 61. The E-Record for ECO Creation

Now, in the ECO creation form, navigate to Tools > View ApprovalsThe Approval History window opens up showingApproval Process= ERES Approval ProcessSubmit Date= 13-SEP-2005 00:13:19Now, click on the Statusbutton.This launches the web page showing the Workflow Activities History (Fig 62).


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Fig 62. A snapshot of the Workflow Activities History concerning our ECO

Engineering > ECOs > Notification

Fig 63. The ECO Approval Notification awaiting my approval

As the Requester for the ECO Approval process, I find the ERES Approval Notification in myWorklist (Fig 63).

Fig 64. The ERES Approval Notification (header portion) awaiting approval of the FirstApprover Saumit Mandal

When the first approver (Saumit Mandal) approves the ECO and validates his decision with his E-Signature, a notification is sent to the second approver Andre Wajda (Fig 65).


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Fig 65. The ERES Approval Notification waiting upon the Second Approver Andre Wajda

When the second approver (Andre Wajda) approves the ECO and validates his decision with hisE-Signature, a notification is sent to the third approver Jean Renoir (Fig 66).

Fig 66. The ERES Approval Notification waiting upon the Third Approver Jean Renoir

This process continues till the fifth and the final approver, Ray Satyajit approves and signs therecord. Thereupon, along with the E-Record for ECO Creation, the E-Record for ECO Approvalalso gets archived in the Evidence Store (Fig 67).

Fig 67. E-Records for ECO Creation and ECO Approval in the Evidence Store

Fig 68 shows the complete E-Record for ECO Approval


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Fig 68. The E-Record for ECO Approval

Refer the Demo 033 ENG ERES ECO Creation Approval in Note 336709.1 for a step-by-step review


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ECO Implementation

The event and its subscription have been enabled.


Select the Transaction TypeENG ERES ECO Implementation.The Attributes and the Conditions would remain the same as what we had employed in ECOCreation. Therefore, we shall not create a new Rule but will simply create a new Usageout of theRule we had defined for ECO Creation. Under the Rulestab, click on the Add Usagebutton.Next, select the option add usage for rule used by another transaction type. When promptedto select the Transaction Type, select ENG ERES ECO Creation from the drop down list. TheRule ENG ECO Creation in V1, M1, M2 and M3defaults since it is the only rule defined for ECOCreation. The Rule is copied for the current Transaction Type.


The Rule Variables are set as EREC_REQUIRED = Y and ESIG_REQUIRED = Y.


Responsibility: Manufacturing and Distribution Manager ResponsibilityEngineering > ECOs > ECOsSelect organization M3.Query the ECO SMECO30.

Select Tools > ImplementWe get the following message at the bottom of the screen:Submitted request 2790579 for ENCACN ECO/Revised Item Cannot be Updated While it isbeing Implemented.

Navigate to the View > Requests screen

Ensure that the request for ECO Implementation completes in Normal status.Now return to the ECO creation screen.We find that the ECO is now in Scheduledstatus.Now, navigate to Actions > eRecord DetailsThis leads us to the Evidence Store where we find three E-Records associated with this ECO (Fig69).

Fig 69. The ECO Implementation E-Record in Pending Status

If we open the ECO Implementation E-Record, we find that signatures are pending from the listedapprovers (Fig 70).


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Fig 70. The E-Record for ECO Implementation is yet to be reviewed and signed

Engineering > ECOs > NotificationThe following Notification is available (Fig 71)

Fig 71. Notification received by approver for validating the E-Record on ECOImplementation

The moment the first approver approves the E-Record and validates it with his E-Signature, anotification is sent to the second approver, and so on.

Fig 72. The ECO Implementation E-Record after it is approved by all approvers

The E-Record displays a status as Complete, after it has been approved and signed by all theapprovers. Fig 73, displays the complete E-Record for ECO Implementation.


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Fig 73. The complete E-Record for ECO Implementation

The ECO will now display the status of Implemented.

Note:Implementing the ECO adds the component Standard Water Tray in Item Sequence 40in the BOM for the Humidifier. This updation of the Bill triggers an E-Record (E-record ID =33083) as seen in Fig 73, since the event BOM Bill of Materials Update is in Enabled status. TheE-Record for the Bill Updation appears as a Child E-Record for the ECO Implementation E-Record.

Refer the Demo 034 ENG ERES ECO Implementation in Note 336709.1 for a step-by-step review

E-RECORDS AND E-SIGNATURES IN WORK IN PROCESS

There are three business events that are seeded and supported for ERES.

Fig 74. Business Events in Work in Process that are seeded and supported for ERES

We shall demonstrate implementation of ERES with the following two business events:WIP Job Assembly MoveWIP Job Assembly Completion

WIP Job Assembly Move



Select the Transaction TypeWIP ERES Job Assembly Move.Under the Attributestab, we select the seeded Attribute WIP_MOVE_TRANSACTION_TYPE.This is an Attribute with a Dynamic Usage defined by the SQL:

select wip_move_validator.move_txn_type(wmt.transaction_id)from wip_move_transactions wmtwhere wmt.transaction_id = :transactionId


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Fig 75. The Text Values to use, if the Attribute WIP_MOVE_TRANSACTION_TYPE is usedin creating a Condition in AME

Fig 75, explains the logic for defining Conditions based on our chosen AttributeWIP_MOVE_TRANSACTION_TYPE. Since we would be using a simple move transaction fordemonstrating ERES for the business event WIP Job Assembly Move, we shall use the valueMove transactionfor creating our condition.

Approvals Management Administrator > Approvals > (T) Conditions

Click on the Add a Conditionbutton.We create the Condition shown in Fig 76.

Fig 76. Our Condition for triggering ERES for the WIP Assembly Move business event

Approvals Management Administrator > Approvals > (T) Rules

Using the Condition defined in Fig 76, we define our Rule (Fig 77).


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Fig 77. Our Rule for the WIP Assembly Move business event


For Transaction Name= WIP ERES Job Assembly Move and Rule Name= WIP Job Move

Rule, we specify EREC_REQUIRED = Y and ESIG_REQUIRED = Y.

Responsibility: Manufacturing and Distribution ManagerWIP > Move Transactions > Move Transactions

Select the organization M3.We pick an existing Released Job and move 2 units from Operation 10 Queue to Operation 10 Tomove. When we click on the button Save, we get the following pop-up (Fig 78).

Fig 78. Pop-up indicating association of a mandatory Collection Plan defined in OracleQuality

This pop-up comes because a collection plan defined in Oracle Quality (discussed under thesection E-RECORDS AND E-SIGNATURES IN ORACLE QUALITY) has been made mandatoryfor data collection during WIP Move transactions. We enter the quality results and once againclick on the Savebutton. This launches the List Of Signerspage. This business event does notallow deferred signature. The signers approve and sign the record online.

ERES User > Evidence Store

Fig 79. The E-Record for WIP Job Assembly Move in the Evidence Store

Fig 80, shows the complete E-Record for this business event.


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Fig 80. The E-Record for WIP Job Assembly Move

Note:We had entered Quality Results for the two units of item SCJ180/20, that were movedfrom Queueof Operation 10 to To move of Operation 10. These Quality Results are clearlycaptured in the E-Record in Fig 80.

Refer the Demo 041 WIP ERES Job Assembly Movein Note 336709.1 for a step-by-step review

WIP Job Assembly Completion



Select the Transaction TypeWIP ERES Job Assembly Completion.Under the Attributestab, we select the seeded Attribute WIP_SUBINVENTORY.This is an Attribute with a Dynamic Usage defined by the SQL:

select mmt.subinventory_codefrom mtl_material_transactions mmtwhere transaction_id in (select transaction_id


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from mtl_material_transactionswhere transaction_set_id =substr(:transactionId, 1, (instr(:transactionId,'-')-1))and transaction_source_id =substr(:transactionId, (instr(:transactionId, '-')+1), (instr(:transactionId, '-', 1, 2)-

(instr(:transactionId, '-')+1)))and transaction_type_id in (44,17)

Note: The Condition we had defined for the event WIP Assembly Move viz.,WIP_MOVE_TRANSACTION_TYPE in {Move transaction}is not available for the the eventWIP Job Assembly Completion as the move transaction type attribute does not apply to WIPCompletion. Thus under the Attributestab, the Attribute WIP_MOVE_TRANSACTION_TYPE isnot available for the event WIP Job Assembly Completion. Instead a new (seeded) AttributeWIP_COMPLETION_TRANSACTION_TYPE appears. We would however, not be using thisattribute.

Approvals Management Administrator > Approvals > (T) ConditionsClick on the Add a Conditionbutton.We create the Condition shown in Fig 81.

Fig 81. Our Condition for triggering ERES for the WIP Job Assembly Completion businessevent


Using the Condition defined in Fig 81, we define our Rule (Fig 82).


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Fig 82. Our Rule for the WIP Job Assembly Move business event

The Rule in Fig 82, implies that ERES would be triggered if an assembly is completed into theFGI or the Stores subinventory.


For Transaction Name= WIP ERES Job Assembly Completion and Rule Name= WIPAssembly Completion in Stores & FGI subinventories, we specify EREC_REQUIRED = Y andESIG_REQUIRED = Y.

Responsibility: Manufacturing and Distribution ManagerWIP > Material Transactions > Completion Transactions

Select the organization M3.We select a pre-defined job that has one unit of item SCJ180/20 as Available to Complete.Click on the Continuebutton. This opens the WIP Assy Completionscreen.Enter Subinventory= Stores, UOM defaults as Ea, enter Quantity= 1.

Since this item SCJ180/20 is a serial controlled item, click on the Lot/Serialbutton. This opensthe Serial Entryscreen. Enter the Start Serial Numberand the End Serial Numberas 123.Click on the Done button. We are back to the WIP Assy Completionscreen. Click on the Donebutton here. We are brought back to the main Completion Transactionsscreen and a messageis displayed at the bottom of the screen (Fig 83).

Fig 83. Message at the bottom indicating that the ERES setup is being validated for theAssembly Completion transaction

After a moments wait, the List Of Signerspage is launched. Deferred signature is not available

for this event. The signers put their electronic approval in online mode.

Once the approvals and electronic signatures are complete, navigate toERES User > Evidence Store

Fig 84. The E-Record is available in the Evidence Store


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The complete E-Record is detailed in Fig 85.

Fig 85. The E-Record for WIP Job Assembly Completion


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Refer the Demo 042 WIP ERES Job Assembly Completionin Note 336709.1 for a step-by-step review

E-RECORDS AND E-SIGNATURES IN ORACLE QUALITY

There are twenty-two business events that are seeded and supported for ERES.

Fig 86. Business Events in Oracle Quality that are seeded and supported for ERES

We shall demonstrate implementation of ERES with the following four business events:QA ERES Collection Element CreationQA ERES Specification CreationQA ERES Collection Plan CreationQA ERES Result Creation


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Case Summary

9

A specific business case has been employed to setup the required business events in OracleQuality for the purpose of demonstrating the requisite ERES setup. This business case has beenadopted verbatim from the business case detailed in the white paper A Guide to Oracle Qualitypublished on the Metalink under Note 248331.1. Therefore, to save on space for the currentdiscussion, we have chosen not to elaborate on the same business scenario in this paper. Like inall our previous sections and to retain consistency in the style of presentation we shall directlylaunch ourselves into a transaction-by-transaction analysis of ERES implementation.

QA ERES Collection Element Creation

Using sysadmin login ensure that the business event and its subscription are enabled.


Select the Transaction TypeQA ERES Collection Element Creation.Click on the Attributestab.Select the seeded Attribute QA_ELEMENT_TYPE.

This is an Attribute with a Dynamic Usage defined by the SQL:

select char_type_meaningfrom qa_chars_vwhere char_id = :transactionId

If I query my instance using the above SQL, for collection element types I find some values (Fig87).

Fig 87. Querying my instance for Collection Element Types

9However, we are aware that Oracle Quality provides us with three predefined collection elementtypes, Attribute, Variableand Reference Information. Each of these has been explained indetail in Note 248331.1. We shall define our Condition and Rule such that whenever a collectionelement of type Variable or Reference Information is created, ERES would be triggered.

Approvals Management Administrator > Approvals > (T) ConditionsClick on the Add a Conditionbutton. Using the QA_ELEMENT_TYPE Attribute, we define aCondition as seen in Fig 88.


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Fig 88. The Condition for launching ERES for Quality Collection Element Creation


Here, we create the Rule depicted in Fig 89.

Fig 89. The Rule for triggering ERES for Quality Collection Element Creation


For Transaction Name= QA ERES Collection Element Creation and Rule Name= QACollection Element Creation we set EREC_REQUIRED = Y and ESIG_REQUIRED = N.

Responsibility: Manufacturing and Distribution ManagerQuality > Setup > Collection Elements

Select the organization M3.We are now in the Collection Elementspage. Here, we enter the values as follows:Collection Element= SHAFT LENGTHSelect from the LOV, Element Type= VariableData Type= NumberReporting Length= 5Decimal Precision= 2UOM= MMWhen we place the cursor on the Default Valuefield, Specification Limitswindow opens up.Here, we enter the values:


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Target Value= 180Specification Range= 179 182Reasonable Range = 178.5 183.5We save our work.

Now, navigate to Tools > eRecord Details.The E-Record is available in the Evidence Store (Fig 90).

Fig 90. The E-Record for Collection Element Creation

The complete E-Record for the Collection Element Creation is displayed in Fig 91.

Fig 91. The E-Record for Quality Collection Element Creation


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In the demo 051 QA ERES Collection Element Creation, we have gone further and defined acollection element of TypeReference Information, to demonstrate the creation of E-Record forthat collection element as well, in accordance with our Rule (Fig 89).

Refer the Demo 051 QA ERES Collection Element Creationin Note 336709.1 for a step-

by-step review

QA ERES Specification Creation

Using sysadmin login ensure that the business event and its subscription are enabled.


Select the Transaction TypeQA ERES Specification Creation.Click on the Attributestab.Select the seeded Attribute QA_ORGANIZATION_CODE .This is an Attribute with a Dynamic Usage defined by the SQL:

select organization_codefrom qa_eres_specs_vwhere spec_id = :transactionId

Approvals Management Administrator > Approvals > (T) Conditions

Click on the Add a Conditionbutton. Using the QA_ORGANIZATION_CODE Attribute, wedefine a Condition as seen in Fig 92.

Fig 92. The Condition for Creation of a Specification in Quality

Approvals Management > Approvals > (T) Rules

Using the Condition created above, we define our Rule (Fig 93).


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Fig 93. The Rule for Creation of a Specification in Oracle Quality


For Transaction Name = QA ERES Specification Creation and Rule Name = QA Specification

Creation in M1, M2 and M3, we set EREC_REQUIRED = Y and ESIG_REQUIRED = Y.

Responsibility: Manufacturing and Distribution ManagerQuality > Setup > Specifications

Select M3 as the organization.In the Specificationsscreen, we define a Specification as follows.Specification Name= SPEC_SCJ180/20Item= SCJ180/20We now click on the Spec Elementsbutton. In the Specification Elementswindow that opensup we enter the details as displayed in Fig 94.

Fig 94. Associating a Specification Element and a Range of with our Specification

We save our work.The Specification is saved in Status= Draft.

Navigate to Tools > Request e-signature approvalThis launches the List Of Signerspage.Deferred Signature is allowed for this event. We use this utility.When the first signer Saumit Mandal approves and signs the E-record and then clicks on theSubmitbutton, a notification is sent to the next signer Andre Wajda (Fig 95).


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Fig 95. Notification received by the second signer Andre Wajda

Each signer responds to the notification by approving it and the notification gets forwarded to thenext approver and so ontill the last approver Ray Satyajit approves and signs it. Now, if the firstsigner or the Initial Requester opens his notification, he finds the following (Fig 96).

Fig 96. Notification indicating that the Specification SPEC_SCJ180/20 has been approved

Fig 97. The Complete Approval Notification


Select organization M3.If we query the Specification SPEC_SCJ180/20, we find the Specification now has a Status =

Approved for Use.Tools > eRecord DetailsThe E-Record is available in the Evidence Store (Fig 98).

Fig 98. The E-Record for Specification Creation


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Fig 99. The E-Record for Specification Creation

Now, in the Specifications creation form, we click on the Org Assignmentsbutton.This opens the Organization Assignmentsform for Specifications.

Note:Since the item SCJ180/20 was created in V1 and assigned to M1, M2 and M3 only, wefind M1, M2 and V1 in the Specification Organization Assignments form (we are already in M3).


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We proceed to assign the specification we created in M3 to M1 and M2. The system adds theorganization code as a suffix to the specification name to create the name of the specification inthat organization. For example, the Specification gets the name SPEC_SCJ180/20 M1in the M1organization.


Select M1 as the organization.Query for the Specification SPEC_SCJ180/20 M1.

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Implementing E-Records & E-Signatures in Oracle Applications