21 CFR Part 11

Dear Forum Members,

Can u make me aware of establishing up Pharma Company’s policy on computer validation with reference to 21 CFR Part 11?

What are the crtical aspects to be included in the above said policy?

Thanking You & Regards,


Hi kvkiran ,

Thats a pretty big question, I would generate an individual protocol on how your company deals with all issues part 11. At Premier Validation we have our own Part 11 document that we use to apply to systems we are working on.

It guides us to ask questions such as:

  • Are there electronic signatures assocaited with the system
  • What type of records are stored
  • Secuity
  • Access levels
  • Audit trail management
  • Log in mechanism
  • Username password (expiry period)

Our document is a concise 4-5 page protocol, if you are interested in obtaining a version of it contact me at my email address below


We wrote a document that is the company’s interpretation of Part 11. It includes requirements to meet Part 11. Then any system that is planned gets this document added to the user requirements.