21 CFR Part 11 Compliance

The FDA has implemented 21 CFR Part 11, Electronic Records, Electronic Signatures, and Final Rule to place paperless record systems under cGMPs. These regulations describe the technical and procedural requirements that must be met if a company chooses to maintain records electronically, or uses electronic signatures.

Numerous inspectional observations of 21 CFR Part 11 deficiencies by the FDA have been noted. These deficiencies include lack of adequate procedures for version control and archival of electronic documents, lack of safeguards to prevent the use of unauthorized electronic signatures, and lack of validation of computerized systems and software, among others.

PSC Biotech, together with our solution partners (see Capabilities) can provide a turn-key program for 21 CFR Part 11 compliance.

Elements of our program include:

  • An inventory evaluation for all GxP systems and associated software applications
  • Gap analysis to identify compliance deficiencies related to the use and control of computerized systems
  • Risk assessments of computerized systems to assist in the prioritization of corrective and preventive actions to ensure Part 11 compliance
  • A remedial action plan documenting planned corrective and preventive actions
  • Resources to implement the remedial action plan
  • Project management to monitor the progress of the agreed-upon action plan

If you would like more information, get in contact with us directly here.