Options For A Computerised System Validation Course

A list of possible topics to be covered on a computerised system validation course.

Possible Topics to be Covered:


  • Presenter and participants introduce themselves
  • List participant learning objectives
  • Overview of the course

Why Validate?

  • Want to validate versus must validate approaches
  • Cost of compliance versus of non-compliance
  • Benefits of validation: delivering a system meeting user requirements

Key Terms and Definitions

  • Define words etc
  • Problems with equipment qualification
  • Introduction to FDA glossary on computerised system validation

The Regulations

  • Scope of regulations and guidelines impacting computerised systems
  • Historical background to regulations on computerised systems in the pharmaceutical industry
  • Overview of regulations and guidelines for GCP and GLP


  • Compare and contrast the two regulations or guidelines for computerised system validation relevant to the client's area.

Regulations and Guidelines

  • GAMP 3: approaches to validation of systems
  • OECD GLP: minimum list of SOPs and an inspectors approach
  • Boehm (1970) why complete validation of a system is a myth


  • Review FDA Warning letters from GLP, GMP and medical device GMP
  • Derive common problem areas with computerised systems

System Development Life Cycle

  • Overview of SDLC: ISO V model and waterfall model
  • Designing Quality validation and verification
  • Documented evidence
  • ISO 9000-3 (ISO 12207) and Tick-IT quality schemes for software
  • What the FDA think of ISO 9000-3

Vendor Audits

  • Rationale for vendor audits
  • How to carry out vendor audits
  • Evidence of system development life cycle activities
  • Reporting the results
  • Vendor management programmes

Medical Device Regulations

  • Discussion on 21 CFR 820: cGMPs for medical devices (Quality System Regulation) for software
  • CDRH draft guideline on General Principles of Software Validation


  • Review General Principles of Software Validation
  • Incorporate key requirements in an updated SOP

Revalidation: All or Part of the System?

  • Revalidation Policy
  • Impact of changes on revalidation: partial, no or full revalidation?

Electronic Signatures and Electronic Records: 21 CFR 11

  • Outline of the key points of the legislation
  • Publication of enforcement policy 30th July 1999
  • Open and closed systems and other definitions
  • Trustworthiness of records: the need for an audit trail
  • Digital signatures and biometrics
  • Legacy systems and electronic records: no grandfathering of systems
  • Impact on manufacturing R&D systems

Workshop on Electronic Signatures and Electronic Records

  • Review the final regulation and derive regulatory requirements

Keeping a System Validated when Operational

  • Change Control and Configuration Management
  • Backups, Recovery, Archive and Restore
  • Disaster Recovery
  • Maintenance of the system

So You Think You are Compliant?

  • Real world IT (Information Technology) Departments
  • Impact of IT on the compliance status of Regulated systems
  • Outsourced operations and service level agreements (SLA)
  • Compliance and IT departments: impact of electronic records regulations


  • Update the audit checklist with points from the operational and IT discussions
  • Review whole checklist

System Retirement and Data Migration

  • Issues covering system retirement
  • Data migration considerations

Review of the Course

  • Discussion of participant learning objectives
  • Discuss issues arising
  • Close of course