Book No.
Books on Part 11:
Electronic Records & Signatures

(click on titles for descriptions)

Total
Number
of
Books

Number with
Custom Covers
23:
Part 11 & Drug Development:  Regulation, Preamble & FDA Guidance on Electronic Records & Electronic Signatures
1A:
Selected Regulations/Guidance for Drug Studies 
1B:
FDA Good Clinical Practice 2011 Reference Guide
2:
Selected Regulations/Guidance for Medical Device Studies
3A:
Regulations/Guidance on the Protection of Human Subjects: Clinical Investigator, IRB & Sponsor Responsibilities
4:
Selected Regulations/Guidance on Good Manufacturing Practice