21 CFR Part 11 Compliance: Systems Documentation

Last revised: 
03/01/2016

Certification
At the completion of validation, you will ‘certify’ that your system has been validated. The certification provides a ‘level of confidence’ that the software is fit for its intended use and account for all activities and work products itemized in the validation plan. Certification is documented in a validation summary report.

Required Documentation
The power of documentation in a validation effort cannot be understated. It’s a regulatory necessity – the agency does not give you credit for work that is not documented. Aside from it being required, it guides you in what to do and helps you remember what you did. Treat it as a critical member of your team worthy of respect and not an undesirable task to be shelved and forgotten. System documents are living documents that require periodic updates in order to accurately depict validation of your system. The following templates are provided for your convenience:

The documents below are available through CTSI Consultation Services.

  • SOPs and User Manuals
  • Verification Protocols
  • Personnel Qualification Records
  • Training Certificates
  • FDA Notification of Electronic Signatures
  • Validation Summary Report