Thank you for contacting Assurea! We provide the following services (although they are not currently applicable for your company based on the info you have furnished)

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  to explore mutually beneficial interactions!