Computer Validation Foundations: Common Sense Practices for Compliance

Instructor: Teri Stokes
Product ID: 700711
  • Duration: 60 Min

recorded version

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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2008

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Read Frequently Asked Questions

Auditors expect to see evidence that these plans have been exercised on an annual basis.


Roles for end user, IT support, and software supplier in the operational phase of a validated system’s life cycle.

When a validated computer system goes live in production use, the process of validation is not over. It has in fact, just begun. Keeping the computer system in a validated state is an ongoing daily effort throughout its operational lifetime and includes its end-of-life decommissioning and replacement. Configuration management of the system must be documented. Formal change control practices and records of formal testing after each change are needed. IT operations logs should show the use of a documented backup and retrieval process. The system should be included in both a business continuity plan and a disaster recovery plan that is approved by management. Auditors expect to see evidence that these plans have been exercised on an annual basis.

Areas covered in the session:

  • Roles for end user, IT support, and software supplier in the operational phase of a validated system’s life cycle
  • Content and structure for a system’s configuration management log binder
  • Change control process and practices
  • Backup and retrieval practices
  • Different roles for online backups, electronic archive, off site storage, and escrow account
  • Ongoing system training and materials
  • Different roles for business continuity plans and disaster recovery plans
  • What auditors expect to see

Who will benefit:

  • Project Managers.
  • Project Leaders.
  • Management Representatives.
  • Management.
  • Team members and those closely involved in the ISO 9001:2000 project.

Instructor Profile:

Teri Stokes, Since 1996 Dr. Stokes has had a successful global consulting practice in computer validation as GXP International. This practice benefits from a background of 16+ years in the computer industry at Digital Equipment Corporation based in the USA and also in Switzerland as well as 12 years as a registered Medical Technologist working in hospital, university, and central medical laboratories. She has authored two books and many invited chapters and journal articles on the subject of common sense computer validation practices.

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