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FDA CFR 21 Part 11: Electronic records: Electronic Signatures

FDA: Food and Drug Administration.

CFR: Code of Federal Regulations.

ERES: Electronic Records and Electronic Signatures.

 

The title 21 of the Code of Federal Regulations, established by the Food and Drug Administration in 1997 (latest review in April 2018) regulates on electronic records and electronic signatures (ERES). Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable and equivalent to paper records and handwritten signatures.

 

FDA CFR 21 Part 11 & EU Annex 11 Requirements

Both the FDA CFR 21 Part 11 and the EU Annex 11 share the mutual goal of safe, validated computer systems for drug manufacturing (GMP). Whereas the Part 11 is a regulation, the Annex 11 is only a guideline to comply with GMP principles within the EU. The FDA CFR 21 Part 11 has an international reach whereas the EU Annex 11 is focused on Europe.

 

Here are some of the industry standards when it comes to complying with the two titles:

•Access limited to authorized individuals using roles; privileges are assigned to role not individuals.

•Specific password security

•Unique user name

•Audit trail for all changes

 

Request the RMS-WP-Vxxx-EN to find out how Rotronic comply to the FDA requirements and the EU guidelines.