Introduction to Validation

1
Introduction to Validation

• Society for Clinical Trials
• Pre-Conference Workshop
• May 2007

2
Agenda

• Introduction of Team Members
• Mark Jones - ProQuis Demo
• Stephen Koffa Validation Documentation
• Sara Levy - Document Management
• Jo Valentine Overview
• What is Validation?
• Why Validate?
• The Fear Factor
• What is Document Management?
• Do We Have to Validate?
• What, When, and How?
• And The Winner Is

3
What is Validation?
Cost
Time
Quality

• Validation-A documented process that demonstrates
  a system was developed, implemented, operated,
  and maintained in a controlled manner and results
  in assurance that the system consistently meets
  specifications and is suitable for intended use.
• Verification - Confirmation by examination and
  provision of objective evidence that specified
  requirements have been fulfilled
• Computer System - Includes hardware, software,
  peripheral devices, personnel, and documentation
  e.g., manuals and Standard Operating Procedures
• Therefore, the scope of validation includes
  implementation of hardware, software, policies,
  procedures, and training of personnel on
  automated information systems (AIS) that house
  FDA-regulated data. Validation is the methodology
  of confirmation that the computer system meets
  requirements and that it complies with internal
  policies and procedures.

4
Validation is an Art

• If you consider that any validation methodology
  is an art and not a science, it may help to
  explain why, within a scientific community, it is
  difficult for people to understand or agree upon
  a concise and consistent practice
• There is no one model that is best but there
  should be one that is best for your organization
• Flexibility is the key to success in finding a
  solution that works within any organization

5
Why Validate?

• Quality Assurance
• Risk Management
• Regulatory Compliance
• Standard Operating Procedures
• Best Practices

6
The Fear Factor

• Guidelines leave Validation open to
  interpretation
• Developing and following internal standards
• Auditable to standards
• Personal accountability
• Time and resource constraints
• Volume of documentation

7
What is an EDMS?

• Document management systems commonly provide
  storage, versioning, metadata, security, as well
  as indexing and retrieval capabilities
• Initially they were designed to offer document
  imaging-level capture, storage, indexing and
  retrieval capabilities
• The applications grew to encompass electronic
  documents, collaboration tools, security, and
  auditing capabilities

8
Do We Have To Validate?

• ???
• ???

9
What, When, How?
V Model of Validation
10
Traceability Matrix (TM)

• Maps System Design Specifications (SDS) to IQ
  Test Scripts
• Maps Functional Requirement Specification (FRS)
  to OQ Test Scripts
• Maps User Requirement Specification (URS) to PQ
  Test Scripts

11
Installation Qualification (IQ)

• The IQ includes the verification of the
  installation requirements, verification of the
  equipment specifications, and verification of the
  installation. The IQ protocol should verify that
  the system meets the System Design Specification
  expectations.

12
Operational Qualification (OQ)

• The OQ is tied to the Functional Requirements
  Specification (FRS). All functions identified in
  the FRS must be tested. Testing includes Unit
  Testing and Integration Testing.

13
Performance Qualification (PQ)

• The PQ is based on the User Requirements
  Specification (URS). Since these tests provide
  evidence for user acceptance, trained key users
  of the system must be involved in PQ testing and
  in review and approval.

14
Audits

• Purpose is to identify process, procedure, and
  objective evidence of a quality system and
  inspect for compliance
• The audit typically verifies the adequacy of
  controls generally focusing on documented
  processes, procedures, and existing documentation
  for all system life cycle activities
• Should be completed for a vendor that will
  provide a product or hosting services

15
Remediation Activities

• Remediation activities are those tasks that are
  required to be completed to amend previous
  Validation activities (commonly as a result of an
  audit)
• This typically involves improving upon or
  correcting previously conducted computer system
  testing and creating, revising, or implementing
  policies and procedures that relate to the FDA
  Regulated Systems

16
Standard Operating Procedures (SOPs)

• System SOPs
• Procedures that describe how to use the system
• May reference User Guides
• Operational SOPs
• Should incorporate the automation being
  introduced by the system that will replace manual
  process.
• Computer System Validation SOPs
• Document Management
• Security (Logical and Physical)
• Training
• Backup and Restore
• System testing (Validation and Verification)
• Change Control and Configuration Management
• Problem Resolution
• Periodic Review and Monitoring
• Disaster Recovery

17
And The Winner Is

• How will you know if you have had a successful
  Validation effort?
• A successful implementation with no bugs
  introduced to your Production environment
• A well documented path from the initial
  validation to the change control process
• A successful audit with no major findings

18
References

• FDA Home page - http//www.fda.gov/
• FDA Glossary of Terms http//www.fda.gov/ora/inspe
  ct_ref/igs/gloss.html
• Guidance for Industry Part 11, Electronic
  Records Electronic Signatures Scope and
  Application http//www.fda.gov/cder/guidance/566
  7fnl.htm
• 21 CFR Part 11 Electronic Records, Electronic
  Signatures http//www.accessdata.fda.gov/scripts/c
  drh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart11

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Other Terms

• Configurable Software Setting system parameters
  as related to a system function
• COTS Commercial Off The Shelf Application
  software, sometimes general purpose, written for
  a variety of industries or users in a manner that
  permits users to modify the program to meet their
  individual needs. Should allow Validation
  activities to be scaled down if vendor has
  adequate System Development Life Cycle (SDLC)
  processes
• Customized Software Software that has been
  designed or altered to individual specifications
  by developers
• Document Capture - Images of paper documents
  using scanners or multifunction printers
• GAMP4 (Good Automated Manufacturing Practices) -
  widely accepted guidance on validation of
  automated systems
• Indexing may be as simple as keeping track of
  unique document identifiers but it may take a
  more complex form, providing classification
  through the documents' metadata or even through
  word indexes extracted from the documents'
  contents. Indexing exists mainly to support
  retrieval
• Integration - Some document management systems
  provide functionality to integrate document
  management directly into other applications, to
  allow retrieval of existing documents directly
  from the document management system repository,
  accommodate changes, and save the changed
  document back to the repository as a new version,
  all within the application. (I.E. Microsoft Word
  or ADOBE PDF files)
• Legacy System A system that has previously been
  implemented
• Metadata - Data about data that is typically
  stored for each document. The EDMS may extract
  metadata from the document automatically or
  prompt the user to add metadata
• Prospective Validation Validation activities
  that are completed on newly implemented systems
• Retrieval in the electronic context can be quite
  complex and powerful. Simple retrieval of
  individual documents can be supported by allowing
  the user to specify the unique document
  identifier, and having the system use the basic
  index to retrieve the document. More flexible
  retrieval allows the user to specify partial
  search terms involving the document identifier
  and/or parts of the expected metadata. This would
  return a list of documents which match the user's
  search terms
• Retrospective Validation Testing and or process
  activities that are completed on a legacy system
• Storage of documents often includes management of
  those same documents where they are stored, for
  how long, migration of the documents from one
  storage media to another (Hierarchical storage
  management) and eventual document destruction
• Version control is the management of multiple
  revisions of the same unit of information.
  Changes to documents are identified by
  incrementing an associated number or letter code,
  termed the version number", and associated
  historically with the person making the change
• Workflow functionality in an EDMS helps
  organizations to specify, execute, monitor, and
  coordinate the flow of work cases within a
  distributed office environment

20
Questions

• Thank you for your time and attention!