With the advent of technology, the FDA has implemented 21 CFR Part 11, Electronic Records, Electronic Signatures, Final Rule, to place to place paperless record systems under cGMP’s. The regulation describes technical and procedural requirements that must be met if a company chooses to maintain records electronically or uses electronic signatures.

Numerous inspectional observations of 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, lack of validation of computerized systems and software among others.

PSC, together with our solutions partners (see Capabilities) can provide a turn-key program for 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 use and control of computerized systems.
• Risk assessments of computerized systems to assist in the prioritization of the 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 progress against the agreed upon action plan.

If you have a need for part 11 compliance services, please Contact Us.