Part 11 Update by Christine Nelson of FDA

Presentation slides for “Update on FDA Part 11 Activities” given by Christine Nelson of FDA at the Biomedical Focus Meeting in July 2001.

The presentation lists the following draft guidances to be issued for comment:
Validation
Glossary
Electronic copies for FDA
Archiving (Record Retention)
Audit trails
Time stamps

It also stresses that paper printouts are not an adequate substitute for electronic records.

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