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Computer Validation Foundations: Common Sense Practices for Compliance
The mutually exclusive roles for Quality Assurance and Quality Control in validation will also be discussed.
Description
Across 20+ years of global regulations and guidance related to computer systems, there are four common themes that provide the foundation for auditable validation efforts.
System validation documentation must provide evidence for three areas of activity and testing is only one of them. The content of a validation package is different for end user performance qualification (PQ) of systems in their work process, for IT installation qualification (IQ) of infrastructure, and for a software supplier's operational qualification (OQ) of a newly developed product. The mutually exclusive roles for Quality Assurance and Quality Control in validation will also be discussed. The emphasis is on experience-based approaches that are known to have worked
Areas Covered in the seminar:
- The four major themes common to all computer related regulations
- A common strategy for preparing all computer validation packages
- Variations on the common strategy for preparing auditable OQ, IQ, and PQ packages
- Industry standard outlines for Validation Plans and Test Plans and why you need both types of plans
- Audit criteria for reviewing computer validation documentation
- The roles of QC and QA in computer validation
Who will benefit:
- System validation teams
- QA & QC professionals
- Software suppliers selling into Bio/Pharmaceutical markets – QA, QC, SDLC managers
- IT managers and staff
- End user purchasers of computerized systems for use in regulated environments – GCP, GLP, GMP, 21 CFR Part 11
- Auditors and consultants
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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