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Project Management Plan forPharmaReady Implementation

Authored By Reviewed By Reviewed OnAshok Vijay Srinivasan 15-December-2015

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Project Management Plan DocumentQAT-03-01-3 Ver.1.5

Template Change HistoryDate Ver.

#Change Description Reason for

Change10-Sept-2012

1.1 Below Points are changed:

1. Section 2.5 Problem Escalation change the word SPEG as EPG2. Section 3, Project Specific Practices- Remove the sentence "Refer tailoring work instructions in Process Management".3. Section 5.4 Remove the contents in the column "Role"

Review comments

May 14 2013

1.2 TOC recreate & In PSP Section (remove the column Quest Tailoring Guideline)

Review Comments

June 7, 2013

1.3 Word Tailoring Guideline removed in section 3 & 5.9

Review feedback Ref Mantis ID 0000207

Jan 13,2014

1.4 In Section 2.3 Stake Holder matrixa note saying "Please specify Participation, Responsibilities & Authorities separately added

In Section 2.5 Problem Escalation- A Line Item “Escalations from Customer” has been added.

In Section 7.5 Backup & Archival- A Note has added to verify the frequency of Verification.

Mantis ID:0000352

Jul 09,2014

1.5 Following sections removedException section 1.4 the column S.No is removed in all tablesSection 2.5- Problem Escalation- “HR Head” & “Quality Head” is modified as “Head HR” & “Head Quality”Section 5.10- Identification of Work products and Review typesSection 6.3-Define process CompositionSection 6.4- Sub processes

Mantis ID:0000407

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Project Management Plan DocumentQAT-03-01-3 Ver.1.5

Section 6.5 Process Performance ModelSection 10.3 Project Review Meetings

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Project Management Plan DocumentQAT-03-01-3 Ver.#1.5

Table of Contents1. Introduction....................................................................................2

1.1 Project Overview..........................................................................................21.2 Project Milestones........................................................................................21.3 Payment Milestones.....................................................................................21.4 References....................................................................................................21.5 Acronyms and Descriptions..........................................................................2

2. Project Organization.......................................................................32.1 Project Team Structure................................................................................32.2 Important Contacts......................................................................................32.3 Stake holder matrix......................................................................................32.4 Project Communication................................................................................32.5 Problem Escalation.......................................................................................4

3. Project Specific Practices................................................................54. Project Life Cycle Model..................................................................55. Project Planning..............................................................................6

5.1 Initial Estimation..........................................................................................65.2 Detailed estimation......................................................................................65.3 Assumptions, Dependencies and Constraints..............................................6

5.3.1 Assumptions..............................................................................................65.3.2 Dependencies............................................................................................65.3.3 Constraints................................................................................................6

5.4 Manpower Resources...................................................................................75.5 Training and Skill upgrade...........................................................................75.6 Hardware Resources....................................................................................85.7 Software Resources......................................................................................85.8 Work environment........................................................................................85.9 Organization process assets.........................................................................95.10 Risks.............................................................................................................9

6. Metrics..........................................................................................106.1 Process and Product Metrics.....................................................................106.2 Quality Assurance Metrics.........................................................................10

7. CBRM............................................................................................107.1 Configuration and Data Management........................................................107.2 Change Management.................................................................................107.3 Build Management.....................................................................................117.4 Release Management.................................................................................117.5 Backup and Archival..................................................................................117.6 Do’s and Don’ts..........................................................................................11

8. Decision Analysis and Resolution Plan.........................................119. Causal Analysis and Resolution Plan............................................1210............................................................Project Tracking, Monitoring and Control

.......................................................................................................1310.1 Project Tracking Records...........................................................................1310.2 Audit Tracking Mechanism........................................................................1310.3 Project Plan Revisit....................................................................................14

11...........................................................................................................................Change History.......................................................................................................15

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1.


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2. Introduction

Project OverviewTAKE has its own product “PharmaReady”, offering for Pharma Companies on the following business functions: Electronic Submissions to different market agencies on the productsStructured Product LabelingDocument Management SystemTraining Records Management SystemPaper publishing Module

This project is for Implementation of the PharmaReady Product for its clients. Take will perform implementation of the Product based on the license procured by the client, by performing IQ and OQ in TAKE’s Custom IQ OQ template that was followed from its 4.3 version of the product.

Any Project management, Risk assessment pertaining to specific implementation will be taken care by the respective customers.

For L0 support the customers will either call the support No. to raise an issue or send a mail to the PharmaReady support mail address. On receiving the Issue support engineer will analyze and provide appropriate resolution to the customer

These issues will be then logged in to the internal Logging system for future references and tracking.

Project Milestones

Milestone Description

Associated Deliverable

Milestone Date

Implementation and Support

Support to associate clients

NA

Payment MilestonesSince this is a support and implementation to the product, payment milestones are not applicable.

Payment Description

Associated Deliverable

Payment Date

Terms of payment

NA NA NA NA


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References

S. No Reference

Acronyms and Descriptions

Acronyms DescriptionsPR PharmaReadyDM Delivery ManagerPM Project ManagerBA Business AnalystDev DeveloperQF Quality FacilitatorTL Test LeadDMS Document Management SystemTRMS Training Records Management SystemeCTD Electronic Common Technical DocumentSPL Structured Product LabelingPMP Project Management PlanPMR Project Metrics ReportPMG Product Management GroupPEG Product Engineering GroupPPM Paper publishing Module


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3. Project OrganizationProject Team Structure

Important Contacts

Exchange of Information Customer TAKE Solutions

Technical NA Vijay [email protected]+91 97431 69668


VP GRC Varadarajan Srinivasan

Sr. Implementation ManagerVijay Srinivasan

Product Engineering TeamSathishGanesanNaveen KumarGanapathy RamanPrabakaranNaushiraDharmaraj

Training TeamPriya Aldam

Quality Team (Rajagopal, Ganesh, Priya)

Implementation LeadAshok

Implementation Engineers Rajesh PrabuSenthil KumarMohan RaJ

PMO TeamAnabaya Selvan

mailto:[email protected]

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Commercial NA Agy T. [email protected]+91 44 4590 9146

Managerial NA Vijay [email protected]+91 97431 69668

Varadarajan [email protected]

Note : since this is a support to all the PharmaReady clients specific customer is not highlighted.

Stake holder matrix

Stakeholder Role PersonParticipation/

Responsibilities/Authorities

PharmaReady Sales Team

Vijay SrinivasanAshokRajesh PrabuSenthil KumarMohan Raj

Participation:Requirement DefinitionElicitation MeetingsStatus Meeting

Responsibilities:

Authorities:

VP GRC Varadarajan Srinivasan

Participation:NIL

Responsibilities:NIL

Authorities:Approve Resource Request

Senior Implementation Manager

Vijay Srinivasan Participation:Status MeetingsReview Meetings

Responsibilities:






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Review PMP

Review PMRTo provide adequate resourcesConflict resolutionPrepare Business Requirement Documents

Authorities:Approve PMPCustomer Patch Releases

Senior Implementation Lead

Ashok Participation:Status MeetingsReview Meetings

CAR Meetings

Responsibilities:Perform New implementationProvide TrainingProvide L0 SupportProcess AdherenceSchedulingProject Data collection and analysisPreparing PMRProject TrackingRisk ManagementIssue TrackingCommunication Management

Authorities:Timesheet Approvals

Implementation Engineer (s)

Rajesh PrabuSenthil KumarMohan Raj

Participation:Review MeetingsStatus Meetings

Responsibilities:Perform New implementationProvide L0 Support


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Authorities:Nil

Quality Team Rajagopal S Participation:Auditing

Responsibilities:Process Awareness to the team

Authorities:Audit Closure

Project Management Office

Anabaya Selvan Responsibilities:PMR Review

Project Communication

Internal External Data for communicationEmail Support communication to the

Clients, Review, Meeting request

Tele-conference Weekly status call with the PharmaReady Engineering Team, Support call with Clients


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Problem Escalation

Escalation Scenario Escalation Path / Role and Person

Team coordination is poor Sr. Implementation ManagerDelivery HeadHead HR

Customer issues (need of customer time, frequent changes in scope, providing information)

Implementation LeadAccount ManagerDelivery HeadBusiness Unit Head

Schedule delays Sr. Implementation ManagerDelivery HeadSenior Management

Payment delays Delivery HeadSenior Management

Manpower allocation /attritions Sr. Implementation ManagerDelivery HeadHead HR

Machine allocation /Unresolved Software hardware issues

Sr. Implementation ManagerDelivery HeadFacilities Management Head

Product Quality issues (Defects high, Customer detects more defects, Rework high)

Sr. Implementation ManagerDelivery HeadTest ManagerHead Quality

Process Quality issues (Nonconformance to QUEST, Process not being followed with spirit, Documentation and Process workflow not in proper sequence, Metrics not collected)

Sr. Implementation ManagerDelivery HeadHead Quality

Escalations from Customer Sr. Implementation ManagerDelivery HeadHead Quality


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4. Project Specific Practices

PSP Description Rationale behind the PSP

Approval details

(Person, Reference)

Usage of Customized templates.

The following are the Custom templates used.

1. Hardware and software requirement documents license wise.

a) PharmaReady 5.x - Enterprise Edition-Hardware and Software Req

b) PharmaReady 5.x - Standard Edition-Hardware and Software Req

c) PharmaReady 5.x -TEST Server-Hardware and Software Req

2. PharmaReady Implementation plan

3. Implementation Completion Report – project closure document from client on project completions.

4. Validation documents:

a) PharmaReady 5 1 X to 6 0 Installation Qualification - Server Upgrade

b) PharmaReady 5 1. X to 5 1.10.2 Installation Qualification - Server Upgrade

c) PharmaReady 5.1 - Installation Qualification – Client

d) PharmaReady 5.1 - Installation Qualification – Server

e) PharmaReady 5.1 -

These custom documents are inherited from the initial version of the product 4.3

Mr. C. Pradeep, Quality Head.


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Operational Qualification - SPL Admin

f) PharmaReady 5.1 - Operational Qualification - SPL Workflow

g) PharmaReady 5.1 - Operational Qualification - DMS Admin

h) PharmaReady 5.1 - Operational Qualification - DMS Workflow

i) PharmaReady 5.1 - Operational Qualification - eCTD Admin

j) PharmaReady 5.1 - Operational Qualification - eCTD Workflow – US

k) PharmaReady 5.1 - Operational Qualification - TRMS Admin

l) PharmaReady 5.1 - Operational Qualification - TRMS Workflow

m) PharmaReady SPL Import Utility Installation Qualification

n) Upgrade Qualification – Server Migration from Version 4.0 to Version 5.X

o) Upgrade Qualification – Server Migration from Version 4.X to Version 5.X

5. User Name- TRAINING CERTIFICATE

6. PharmaReady Training Guides

5. Project Life Cycle Model

List of standard processes

List of tailored processes List of improvements deployed

L0 support life cycle defined in the Quest is applicable.

Refer PSP section At present, Nil.


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1. Take will perform implementation based on the implementation plan prepared and accepted by customer

2. Take will perform IQ and OQ with TAKE’s Custom template3. On successful completion of the implementation “Implementation

completion Certificate” will be obtained from the customer4. For L0 Support on receiving issues entire by mail or phone call Support

engineer will analyze and provide appropriate solutions. Record the issue in the internal logging system for future tracking.

6. Project PlanningInitial Estimation

Estimating component During Proposal Agreed in SOW/Initiation

Effort NA As per release plan

Schedule NA As per release plan

Cost NA NA (as this is an internal product development)

Resources 4 FTE

Detailed estimation

Estimating component During Proposal Agreed in SOW/Initiation

Effort NA As per release planSchedule NA As per release planCost NA NA (as this is an internal

product development)Resources 4 FTE

Assumptions, Dependencies and Constraints6.1.1 Assumptions

1. TAKE will participate only in the Implementation and support to customer and all the Project management for the individual customer will be taken care by respective customer


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2. TAKE will perform IQ and OQ with its template that was in place since the 4.3 version of the product

3. Temporary additional resources if any will be added on need basis.

6.1.2 DependenciesDelay in clarifications (if any) from the customer will delay the problem resolutionIf there are any issues that requires deep troubleshooting would require support from the product engineering team

6.1.3 ConstraintsNot foreseen any as of now


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Manpower Resources

Role Number of Resources

Skills requiredManagerial/ Domain/

Technical

Skills availableManagerial/

Domain/ TechnicalSenior Implementation Manager

1 Project Management Skills

Domain skills Communication Leadership Inter Personal

skills Problem Solving

and Facilitation skills

Measurement techniques

Review techniques Process awareness

and understanding Implementation

Skills

AvailableAvailableAvailableAvailableAvailableAvailableAvailableAvailableAvailable

Senior Implementation Lead

1 Domain skills Communication Leadership Inter Personal

skills Problem Solving

and Facilitation skills

Measurement techniques

Review techniques Configuration

Management Process awareness


skills

AvailableAvailableAvailableAvailableAvailableAvailableAvailableAvailableAvailable

Implementation Engineers

2 Communication Process awareness


skills

AvailableAvailableAvailable


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The required resources have already been identified. Since the identified resources have the expected skill and no gaps found between required and available, no training is envisaged at this juncture. In case of any change in the stakeholder matrix and if there is any gap in the expected skill, necessary training would be planned and imparted

Training and Skill upgradeSince the identified resources for this PharmaReady implementation have already been worked in various modules of the existing application and if required, the training needs would be identified and tracked to closure.

PharmaReady product Skills required as follows1. Product Orientation -Learner Level

In case of external training, necessary approval shall be obtained from GDH and the training request would be sent to the Training department for further course of actions.

Role MemberTraining required

on

Training Waived Yes/No

Waiver Reason

NA NA NA NA NA


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Hardware Resources

Device type <Server, Work stations, Printers

etc>Numb

erHardware Specifications (*

also specify dedicated/ shared)

Server (Demo and Internal UAT for new product changes)

2 One server with 64-bit and other server with 32-bit, Quad core with 1.6GHz or faster processor , 4 GB RAM, 80 GB Hard Disk Space for system drive, minimum of 130 GB of Hard disk space for Data, 1024 x 768 or higher-resolution display, Network Adapter Card, Fast Ethernet NIC

Standard Desktop/ Laptop 4 TAKE’s Standard Operating system.

Software Resources

Software Number of installations inside the project team

Additional Specifications

Windows 2008 Server

2 1 32 for Demo 1 for Testing

Windows 7 OS 4 Senior Implementation Manager, Implementation Lead, Implementation Engineers

MS Office 2007 4 Senior Implementation Manager, Implementation Lead, Implementation Engineers

SQL Server 2008 Server

2 1 for Demo1 for Testing.

Work environment

Work stations

Software

Back up facility

Facilities Communication

Shall be as per the

Shall be as per the

SVN backup shall be taken

:: As per the PM’s

:: Outlook shall be configured in the


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section 5.6. section 5.7.

on weekly basis i.e. last working day of the week. The desired backup shall be taken by the support team.

request and approval from QH, SVN rights shall be set by Infrastructure team.

:: Conference room with STD facility shall be made available for tele-conference with PR Engineering Team

entire team member’s machine.


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Organization process assetsThis project shall inherit and use the following from the organization’s process assets viz. Process Capability Baseline, Risk database, Best practices and Lessons learnt.

RisksAll the project risks are listed and tracked through Risk Track Sheet, which is available in the following path Add the SVN path


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Metrics

Process and Product MetricsIssue Category Brief or Description SeverityProduction Issue Response time SLA is

applicable.Production Issue Resolution time:

Patch deployment should be made as per committed schedule with the goal of 90%.

New defects injected per request can be accepted up to 15%.

Incorrect patch or fix can be accepted up to 15%.

"block", "crash", “Feature”, “trivial”, “text”, “tweak”, “minor” and “major”

Quality Assurance Metrics

S. No Name UO

MLCL

Baseline

ValueUCL LSL SL USL

1 Process Conformance Score % - 75.00 85.00 100.0

0

7. CBRMConfiguration and Data ManagementSVN is identified as the configuration management tool for artifacts and document base.

The list of configurable items would be identified and tracked in the CI Data Track sheet, which is available in

The following work sheets (Tabs) would be made available in the CIDTS

o Folder Structure Rights: In this sheet, SVN folder structures that are created for this product is mentioned. This sheet would contain the information of top two levels of folder structures, “access rights


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for each folder and roles” and “the snapshot of SVN folder structure that is created for this product”.

.o Configurable Items: The configurable items (CI) for this project are

identified and mentioned in this sheet. The following are a few key info of each CI that are being tracked here i.e. “file naming convention”, “baseline criteria & version”, etc,.

o Data and Records: All the documents and the records that are maintained for this product with its full path and naming convention are recorded here.

o Managed and Controlled: Managed and Control items are identified and mentioned in this sheet. The following are a few key info of each Managed and Control that are being tracked here i.e. “file naming convention”, “baseline criteria & version”, etc,

o CI Version History: The version of the CI’s is tracked here specifying the current and obsolete versions. Movement to the controlled area is also recorded in this sheet along with the baseline request information.

o CI Baseline: The entire work product’s baseline versioning information is maintained here along with the common baseline

Change ManagementNANote: Since this is a Support project Build management is not applicable


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Build Management Line item Value

NA NA

Note: Since this is a Support project Build management is not applicable

Release ManagementNote: Since this is a Support project Build management is not applicable

Line item Value

Backup and ArchivalLine item Value

Respective customer will take care of backup of their servers based on their internal policy. For the local assets and repository will be backed up as per Infra team backup process.

Do’s and Don’tsS. No

Do’s

1 Adhere to Software support Processes defined in the QUEST2 Check-in all the items that are Checked-out before leaving3 Submit the timesheet weekly onceS. No

Don’ts

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3 Never check in code that throws error during compile.5 Do NOT check-out a file for a longer period6 Do NOT login into SVN using other’s ID

8. Decision Analysis and Resolution Plan

This section will be filled when DAR is performed

9. Causal Analysis and Resolution PlanThis section will be filled when CAR is performed.

10. Project Tracking, Monitoring and ControlProject Tracking Records

S. No

Components to track

Tracking Mechanism

Reporting

ModeFrequen

cyTarget

Audience1 Effort /

ResourcesProject server 2007

Portal Monthly Support Team

2 Issues in Mantis

Mantis tool Portal Monthly Support Team

3 Risks Risk Track Sheet Excel Continual Support Team5 Metrics Project Metrics

ReportExcel Continual Support Team

Audit Tracking MechanismS.No Components to

trackTracking Mechanism

Reporting Mode

Frequency Target Audience

1 Internal Quality Audit

Project Audit Record

Compliance Management System

As per the schedule publish by the Quality team

Senior Implementation Manager


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Project Plan RevisitFor every planned deployment, effort and schedule will be arrived. Revisit to the plan can happen in the following scenarios

Changes in resources Reviews and analysis by Quality department, Senior management

Kindly note that there are many sheets getting linked in PMP like DAR sheet, CAR sheet, Risk track sheet and PMR. When they get tracked as part of tracking mechanism, PMP version does not get changed but if there are changes to base data like goals, decisions, defect causes, risks – appropriate sheets get changed and PMP also get changed.


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11. Change History


Date Ver.# Change Description Reason For Changes

15-Dec-2014 1.0 Created the initial version

Initial Version

10-Apr-2015 1.1 Updated the resources, PSP.