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Migration of Controlled Do ments intoDocuments intoCompliant SharePoint Document ManagementSystems
Presented by:Joe LucadamoF d C l iFocused Consulting
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or anychapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated.
These PowerPoint slides are the intellectual property of the individual presenter p p y pand are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc All other trademarks are the property of theirInformation Association Inc. All other trademarks are the property of their respective owners.
2www.diahome.orgDrug Information Association
What is This Presentation About?
• Overview of SharePointOverview of SharePoint– What it is, how it’s structured
To provide framework for this presentation– To provide framework for this presentation
• The migration process
• How to validate migration to SharePoint
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What is This Presentation Not About?
• How to configure SharePointHow to configure SharePoint
• How to validate SharePoint
S ifi fi d i d Sh i• Specific configured or customized SharePoint solutions
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Presentation Assumptions
• SharePoint is validatedSharePoint is validated
• SharePoint implementation meets some or all of the regulatory requirements for complianceof the regulatory requirements for compliance document management
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Key Terms: Traditional EDMS vs. SharePoint
Traditional EDMS
• Current market leaders in EDMS• Documentum solutions, QUMAS
SharePoint
• Microsoft EDMS, collaboration, and web site software, Q
DocCompliance, Pilgrim, MasterControl, etc.
• Typically dedicated to compliance EDMS solutions
• Highly configurable but not out‐of‐the‐box dedicated compliance EDMS
• FDA‐regulated industries showing increasing interest in SharePointEDMS solutions
• Key Terms:• Document as a combined object (content, renditions, metadata,
increasing interest in SharePoint• Key Terms:• Document as multiple objects• No PDF renditions
previous versions)• PDF Renditions• Content Databases: Oracle, MSSQL
• Content Databases: MSSQL
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Migrations from One Traditional EDMS to Another
Traditional EDMS Different Traditional EDMSTraditional EDMS Different Traditional EDMS
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Migration from Traditional EDMS to SharePoint
Traditional EDMS SharePointTraditional EDMS SharePoint
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Traditional EDMS Document Objects
Traditional EDMS D t Obj t Document ObjectDocument Object Document Object
Native ContentAn electronic “document” consists of native content, metadata, signature data, and a dynamically generated PDF
Metadata
rendition.
This is represented as one document object in the system – the user sees onl one entr Signature Dataonly one entry.
Whereas in standard SharePoint systems…
PDF Rendition
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SharePoint Document Objects
Document Object 1 Document Object 2
Document Object
Document Object
Native Content
Metadata
PDF Content
MetadataMetadata Metadata
Signature Data
Signature Data
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Traditional EDMS Architecture
Traditional EDMS A hit t PDF Render Other EDMSArchitecture PDF Render
SolutionOther EDMS ComponentsCustom solutions that sit directly on a
database layer.
EDMS SolutionThese solutions are designed to meet compliance requirements for FDA‐regulated industries. EDMS SolutionTraditional EDMS products typically have an integrated PDF render solution.
DatabaseDrug Information Association www.diahome.org 11
SharePoint Architecture
Sh P i t A hit tPDF Render Other EDMS
SharePoint Architecture Solution ComponentsSharePoint is a standardized EDMS platform, that is designed to meet generic document management
EDMS Solutionneeds.
Customized EDMS solutions sit on top of the SharePoint platform to meet ind str specific req irements
SharePoint SharePoint API
industry‐specific requirements.
SharePoint does not provide an integrated PDF render solution.
MSSQL DatabaseThe SharePoint API is used to interact programmatically with the SharePoint platform.
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Migration As It Is Perceived
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Migration in Real Life
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Migration Process Stages
Export Transform LoadExport Transform Load
Compliance complexity is the greatest at the Transform stageg g
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Export: Introduction
Exporting from an existing solution isExporting from an existing solution is straightforward, provided you account for the
following key components:following key components:
• Document metadata• Document content (native and renditions)• Electronic signatures• Change Request history• Audit information
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Export: Risks & Mitigation
D t • Proper requirements definition• Content counts to verify source and exported documents
Documents Missed
• Clean‐up in the source system, if possible• Clean‐up during the Transform stage
Corrupted Clean up during the Transform stage
• Customize destination system to work with available dataData
• Establish timeline to close out all open revision cycles in the source system prior to export
Open Change Requests
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Transform: Introduction
• The work of transformingThe work of transforming data requires the skills of:– Subject Matter Experts– Subject Matter Experts
– Technical Experts
Y t t f• You cannot transform your data until you know what it i d h it i iis, and where it is going
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Transform: Planning
• What business requirements are driving this new implementation?
• What changes would you like tomake inBusiness
Requirements What changes would you like to make in the new system?
Requirements
• What changes do you have to make to the data to meet new system requirements?Technical data to meet new system requirements?
• What can you do in the new system that you couldn’t do before?
Technical Requirements
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Transform: Typical Business Requirements
Document Type Custom AttributeDocument Type Consolidation
•Streamline system configuration
•Revise design to
Custom Attribute Cleanup
•Modify existing values to meet new syntax
Existing Attributes
•Map existing attributes to new attributes
New Attributes
•Determine rules for populating new attributes•Revise design to
meet current business needs
syntax•Correct data inaccuracies
attributes•Identify attributes to be brought over “as‐is”
•Identify attributes
attributes•Assign SMEs to generate the new data
to be transformed
Proper planning at this stage is critical to defining the scope of the migration effort. Key compliance data must be maintained.
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Transform: Typical (Hidden) Technical Requirements
Critical Compliance Data
• Document Names/Numbers
• Document Titles
New Required Data
• New mandatory system attributes
• New system
Data Type Matching
• Special characters• Date/DateTime matchupsD t l• Document Titles
• Document relationships/references
• SignaturesR diti
• New system architecture/functions
• Data cleanup
• Renditions
The technical team should review these key requirements and provide feedback to the business team to finalize requirements.
Not everything will match one‐to‐one. As a result tools, processes, and procedures must be developed to get your data technically ready to meet SharePoint
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must be developed to get your data technically ready to meet SharePoint requirements.
What About Electronic Signatures on Exported Content?
• Content may be migrated as‐is• Some banding/watermarking may need to be d d i t
PDFs Contain
done during exportSignatures
• A tool may be needed to extract metadata signatures and fuse them to the exported PDF file
PDFs Do N t C t i signatures and fuse them to the exported PDF file
• Rely on a custom SharePoint solution to replicate the functionality of the legacy system
Not Contain Signatures
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Transform: Risks & Mitigation
• Proper requirements definition• QA Verification Plan• Automated data verification against destination system
Improper Data Transformation
• Manual correction of contentf bl d
Content Corruption/Missing • Mitigation strategy for unrecoverable documentsCorruption/Missing
Data
• Make corrections in the Source System prior to export• Automate transformation as much as possible• Be quick!
Production System Down/Frozen
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Transform: Compliance
Validate•Validate all tools•Validate the process
Rules
QA Approval
Rules
•Document transformation rules QA Approval
•QA sign‐off on all transformed metadata
rules
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Transform: Key Pitfalls to Avoid
Electronic Rendition dElectronic Signatures
• How are
Rendition Management
• Do all content
Metadata
• Will all signatures manifested in the current
files have PDF renditions for controlled
attributes exist in the next system?
system? • Are they applied to renditions on
viewing? • Do they need to be modified for
• How will the values for new attributes be
the fly, or stored in the repository?
storage in the new system?
determined?
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Load: Introduction
• Importing to SharePoint requires planning for how and where Planningyou’ll store your data
• Standard, base SharePointd h l
Load• Customized SharePoint solutions• COTS EDMS SharePoint
Load Requirements
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Load: Where is Data Loaded?
Other EDMSRender Solution Other EDMS Components Load utilities talk to
SharePoint via the API
EDMS Solution
SharePoint SharePoint API
Database Layer
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Load: Understanding Content Requirements
Previous Versions
• Determine if
Native Content
• Migrated
PDF Renditions
• Understand
Permissions
• Document previous versions are required in the
content may look different than content created in the
the rendition management solution
• Ensure your
permissions must be set by the API during importthe
compliance SharePoint EDMS
h b
created in the new system
•Metadata gets fused into d
• Ensure your migrated PDFs won’t be overwritten –h h
import• They should match library and content
• Can this be stored in an archive?
document properties for all documents
they have signatures embedded!
type settings
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Load: Things to Consider
How are Renditions Managed?
•Unlike a traditional EDMS content
Historic Electronic Signatures
• If they’re on the PDF, you need to
Are Documents Keeping Their Version
Number?
• SharePoint doesn’t allow the manual
Data Verification
•All good migration tools verify dataEDMS, content
objects in SharePoint will always exist independently
•Will both the native d PDF diti b
you need to understand the render solution
• If they’re metadata only, how will they
if t Eff ti
allow the manual setting of a version number via the API
• To load a document as v4.0, the import t l t h k
tools verify data against a configuration prior to load
•Ensure that:and PDF rendition be loaded to the same library?
•How are the native and PDF rendition l k d
manifest on Effective copies?
tool must check a document out and in 4 times to set the version label to 4
•This will add to the l d
•All required fields are completed
•All of the fields match the target data type
linked? load time •Any list‐driven values match the value on the list in the system
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Load: Archiving Options
Legacy System Database File Share SharePoint
• Keep system running
• Limited b f
• Metadata• Content files either in DB
fil h
• Spreadsheet of metadata
• Content Fil
• Simple library with “text” metadatanumber of
licensesor file share
• Accessible via report
Files metadata• Content files are stored directly withdirectly with metadata
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Quality Oriented Migration Phases
Plan Development Validate Migrate
Overall Project Planning Migration
Utilities
Export
Overall Technical Analysis
Create/Modify Utilities Based
on Requirements
Transform
Requirements Gathering
qMigration Process Load
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Data Migration Validation Deliverables
Plan Develop Validate Migrate
Data Migration Plan
Data Migration Test Protocol•Export•Transform•Load
Data Migration Utilities
•Load•Post‐Load Verification
Migrated Production Data
Data Migration Requirements
Data Migration Summary Report
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Key Data Migration Validation Deliverables
Data Migration Data Migration Data Migration Test Data MigrationData Migration Plan
• Outlines the approachE l i th
Data Migration Requirements
• Detailed export requirementsD t il d i t
Data Migration Test Protocol
• Protocol Wrapper• Export Test Script
Data Migration Summary Report
• Documents results of Data Migration• Explains the
source and destination systems
• Defines roles and
• Detailed import requirements
• Field mapping• Guides d l t f
• Transformation Verification Script(s)
• Load Verification S i t
Migration validation testing
• Prerequisite of releasing system to production• Defines roles and
responsibilitiesdevelopment of any custom tools
• Provides traceability for Data Migration
Script• Error Handling Check
• Post‐Load Processing
to production
Data Migration Test Protocol
Processing• Version up• Retire• Periodic Review
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Succeeding in Your Migration
Plan Prepare Process ProsperPlan Prepare Process Prosper
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Conclusion
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Questions
Joe LucadamoFocused Consulting
jl d @f d l i
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jlucadamo@focused‐consulting.comBooth 109