21 CFR 11

Electronic Records. Electronic Signatures.

FDA requirements for electronic records and electronic signatures are defined in 21 CFR Part 11.

These requirements apply to all

  • Electronically stored data which replace paper-based quality records
  • Electronically signed data which replace a handwritten signature under quality records, where such a signature is required by othe FDA regulations, e.g. 21 CFR 820

 Some examples:

  • Quality data (e.g. sample analysis) recorded in production or quality control
  • Electronic documents maintained in a document management system
  • ERP systems that process and store GMP relevant data
  • Clinical data collected in a clinical study

The Capamed Advantage:

  • Advice on how to implement compliance with 21 CFR 11
  • Cost-effective options for the evaluation of your software products
  • Planning and execution of validation activities for 21 CFR Part 11 compliance