San Diego '99
Infrastructure SOPs for FDA Rule 21 CFR 11
- Topic Area:
- Track: General Topic
- Topic: Documentation
- Type: Breakout Session
04:30 PM Duration:
- Pamela Campbell
- Senior Consultant, First Consulting Group
- This session looks at what processes must be implemented and documented in SOPs for the computing infrastructure to meet and support FDA requirements of rule 21 CFR 11, Electronic Records; Electronic Signatures. This session will look at the general topics and provide sample questions system managers must answer to be compliant with the FDA’s rule 21 CFR 11. These suggestions are based on the real life experiences the presenter has had while working for various pharmaceutical clients.
These suggestions are also applicable to infrastructure requirements for the new EPA, HCFA and DOD rules pertaining to electronic records and electronic signatures.
- To provide system managers and data center managers with a basic list of FDA validation SOPs
- Prerequisites for attendees:
- Required Skill Level:
Assumes general knowledge of topic, familiarity w/basic terms & procedures
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