Overview of the key requirements ofelectronic data management systems in relation to pharmaceuticals and healthcare facilities. This includes the importance of computerised systems controls and defenitions of data. The presentation includes the importance of validation and quality assurance aspects.

1. Electronic Data Management Systems
Tim Sandle

2. EDMS in a Multi-site business
What is the purpose of a DMS?
• Control of Documents, Files or Data!
• The same document/Data available to all users
• A Standard approach to Review and Approval
• Lifecycles
• Obsoletion / Version Control
• Revision History
• 1 Repository for all documents/data (ideally)

3. EDMS in a Multi-site business
Imagine the following:

4. EDMS in a Multi-site business
What is the purpose of an EDMS?
• Everything from DMS plus a lot more!
• Traceability (Audit trail)
• Ease of Access + Access Control
• Control of Users – password and training
• Ability to be used in Multiple locations
(on and between sites)
• Automatic back-up of files/data
• Paperless system and/or controlled printing
• Always use the most current version
• Speed + Use the best resources in your company

5. What Do You Need from a System?

6. System Considerations
• Document or Records Management?
• Is there a difference?
• Documents – Approved files that provide information and allow for a
consistent approach (eg. SOP, Analytical Method..)
• Records - Documents where information is recorded by a user on the
document
(eg. Form, Worksheet… can be electronic or paper)
• Documents are usually stored as template/approved file
• Records are usually stored as data/pdfs and are unique
• There is a HUGE difference in the requirements of the system

7. Documentation/Data Systems –
EDMS, LIMS, Deviations and MRP
One Size fits all?.........No
Understand what you need for your application
• EDMS – Management/Control of documents
• LIMS – Management of Data
• Deviations – Control of Investigations and Approval
• MRP – Everything!

8. EDMS
Document Management System
• Example – Documentum. Used for Documents
• Audit Trail
• Access Control
• Controlled Printing
• Version Control
• Revision History
• Document Lifecycles
• Interface With other systems etc.

9. LIMS
Laboratory Integrated Management System
• Example – Starlims. Used for Data
• Modular Approach
• Interface with other systems
• Data Acquisition
• Data Integrity
• Validation – off the shelf available
• Audit Trail

10. Deviations System
Example – Trackwise. Used for Records
• Often Stand-alone (often Paper)
• Repository for Information
• Unique, Generation and Approval
• Search Ability
• Link to Batch Records
• However, some systems are also able to retain data –
providing clear traceability and robust audit trails. (eg.
SAP–CAPA)

11. MRP
Materials Requirements Planning
Manufacturing Resource Planning
• Example – SAP. Used for both…..
• Data, Document and Record Management
• Planning
• Manufacture
• Testing
• Deviations
• Release
• Or Manual Links to other systems
• Has its limitations, but provides a ‘Neat package’
• LIMS Tends to be kept separate

12. LIMS in More Detail
• Number of Bespoke packages available
• Primarily for Data Capture, but Document management
available
• LIMS is Modular – take as much or little as you like!
• 21CFR Compliant – Access and Data Integrity
• Validation – off the shelf and frequently able to
purchase validation package with the LIMS system

13. LIMS in More Detail
Modular Approach – Core Functions
• Sample Management
• Barcode
• Lab Workflow
• Scheduling
• Electronic Worksheets
• Acquire Results
• Reports
etc.

14. LIMS in More Detail
Modular Approach – Additional Functions
• Stability Studies
• User Qualifications
• Document Management (eg. SOPs)
• Specifications
• Reagent/column management
• Investigation tools
• Equipment maintenance
etc.

15. LIMS in More Detail
Links to External Systems
• SAP
• Other MRP systems
• E-mail
• Desktop Tools
• CDS
• Complex Instruments
• Simple Instruments
• Handheld

16. LIMS in More Detail
Requirements of a LIMS system
• Sample Tracking – demonstration that the appropriate work
is properly completed and the workload is managed
• Sample analysis must be documented – raw data must be
maintained to reconstruct and defend the result
• Results must be organised – reported in a manner that is
understandable and meets the requirements of the end
user.

17. LIMS in More Detail
Key Actions forming the core of an automated LIMS
• Data capture – either manually entered or captured
electronically through such mechanisms and file parsers
• Data analysis and organisation – Includes adjusting
significant digits and checking against limits
• Reporting of the data
• Lab Management functions – provision of support functions
such as tracking and workload assignment
• System Management Functions – such as audit trails and
archival functions

18. LIMS in More Detail
Data Acquisition
• Most equipment available in the lab have data ports
• Very Old Equipment can be an issue (20+ years)
• Most modern Equipment has Data ports (5-20 years)
• New Equipment usually has been designed to interface with LIMS
• LIMS - web based applications
• Global functionality
• Information Sharing
• Search functions
• Data security – encryption (21CFR Pt11 compliant)

19. The Global Challenge
Access
Format
Users and Signatures

20. The Global Challenge
– Access, Format, Users and Signatures
Access
• Local or global access control?
• Links to other packages
• Version alignment
• Standard Packages
• Validation
• Cost consideration
• Helpdesk – Language Barrier?
• Time Zones
• Backup, Indexing, Maintenance and Upgrades – impact to users
• Data Transfer rate and Caching
• Who has access and at what level?
• Commercial and/or Development?

21. The Global Challenge
– Access, Format, Users and Signatures
Format
• Date and Time
• Date – specify format
• Paper size
• Margins
• Headers and Footers
• Language
• Character Recognition – standard fonts

22. The Global Challenge
– Access, Format, Users and Signatures
Users and Signatures
• Different requirements around the globe
• Password Control
• Control – 21CFR Part 11
What is 21CFR Part 11?
• Code of Federal Regulations
• Section 21 = Food, Drink and Pharma.
• Part 11 = electronic signatures and records.

23. The Global Challenge
– Access, Format, Users and Signatures
The Code of Federal Regulations, Title 21, Part 11
(21CFR11) sets forth the:
• USA regulation, but adopted worldwide (USA regulation
was first to be drafted in a useable manner).
• Various standardised controls for ways to access
computers, and how logs of events are maintained.
• Can be used to implement a paperless solution. In theory.
• No major changes to 21CFR Part 11 in last 5 years

24. The Global Challenge
– Access, Format, Users and Signatures
21CFR Part 11 Sets forth:
“Criteria under which the agency considers electronic
records, electronic signatures, and handwritten
signatures executed to electronic records to be
trustworthy, reliable, and generally equivalent to paper
records and handwritten signatures executed on paper”
The rule governs electronic records throughout their
lifecycle from creation through modification, storage, and
final transmission to the FDA

25. The Global Challenge
– Access, Format, Users and Signatures
The three essential elements in a 21CFR11
compliant system are:
• Security of data
• An audit trail showing who has accessed
production files and the changes made
• The ability to report the information required to
demonstrate compliance

26. The (often ignored) challenge
- what does the user require?
• “Fit for Purpose”
• Simple
• User Requirement Specification (URS)
• Not what does the package do that we would like!
• Bespoke packages able to be customised – only use the functions
you need from the package
• Consider the impact on Validation
• Are the systems for Commercial or Development use?
• Does the system need to be GXP compliant?
• GAMP?

27. GAMP
Good Automated Manufacturing Practice
• GAMP is a combination of industry best practices brought
together as a set of guidelines.
• These guidelines are for pharmaceutical manufacturers and users/developers
of computerised systems with GMP impact, such as EDMS.
• GAMP forms a framework of guidance for any GMP
computerised system
• It includes information on how to ensure such systems are controlled and fit
for purpose
• The current GAMP manual, Version 5 consists of one core
volume with a family of Good Practice Guides. It includes
complying with 21CFR Part 11 and the validation of GMP
relevant Systems.

28. GAMP
Principles of GAMP
• Consistent approach to Electronic Records Management
• Manage risk by
• Defining minimal acceptable standards
• Applying stronger measures only where warranted
• Minimal impact on transition from old compliance programs
to new
• Encourage and facilitate new technologies that may involve
electronic records and/or signatures
• Consider and comply with international regulations
• Including US FDA, EU, PIC/S Guidance, Japanese MHLW

29. GAMP
Key Concepts of GAMP
• Scalability of assessment process based on record impact
• Direct Impact records have obvious and significant effect on public health
• Indirect Impact records that provide evidence of compliance but do not have
obvious and significant effect on public health
• Non-impact records that have negligible or no effect on public health
• Identify the potential hazards
• Possible occurrences that could threaten a record
• Including Power failure, security breach, virus and attempted fraud
• GAMP’s 3-component Risk Assessment
• Degree of harm
• Probability of fault
• Detectability of fault

30. The Ultimate challenge
- what does the Quality Systems require?
•Primarily……. Traceability
•Access to all data
•Clear Audit Trail
•A clear visibility of approval of Documents and
Records
•Preferably 1 system!

31. System Validation
The Mantra - Keep it simple!
• URS, DQ, IQ OQ, PQ (PV?)
• Global URS, DQ, IQ and OQ. Local PQ
• Understand your needs
• Validate the activities you need to use – turn everything else
off…
• System Upgrades
• Revalidation
• Impact to other systems

32. Summary
Key to Document and Data Management Systems
• Simplicity
• Provide what the user requires
• Controlled Document Lifecycles
• Traceability of Data
• Communication between the systems used (ideally 1!)
• Visibility and Audit Trail