Dear %USER_NAME%,  thank you for contacting Assurea!  Based on the information provided, we can assist you with :-

Part 11 or Annex 11  Compliance

User access verification
Audit Trail 
Operational system checks 
Electronic Signatures linkage to handwritten signatures
Tools to protect your documentation “to enable their accurate and ready retrieval throughout the records retention period.”
Validation of computerized systems

Contact us at mail@assurea.llc for a Comprehensive Part 11 Assessment & Deliverables needed