Thank you for contacting Assurea!  Based on the information provided, we will be privileged to assist you with the following:-

Part 11 or Annex 11  Compliance

In order to be Part 11 compliant, the following controls need to be in place:
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 for a Comprehensive Part 11 Assessment & Deliverables needed to be compliant and compatible 

Action Items for QMS 

Minimum Quality Foundations 
Doc Management 
Part 11 Signatures
Change Control 
Vendor Management 
Incident Management

Please email us at mail@assurea.llc  for further info as needed