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Infrastructure SOPs for FDA Rule 21 CFR 11
Topic Area:
Track: General Topic
Topic: Documentation
Type:  Breakout Session

Schedule:
11/08/99   04:30 PM     Duration: 90 Min.     Room: 11B

Presenter:
Pamela Campbell
Senior Consultant, First Consulting Group  

Abstract:
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 FDAs 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.

Objectives:
To provide system managers and data center managers with a basic list of FDA validation SOPs
 
N/A
 
N/A  

Prerequisites for attendees:
None

Required Skill Level:
Intermediate
Assumes general knowledge of topic, familiarity w/basic terms & procedures

                                                                                                                                                                           

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