Here are your QARA Results!

You need to be Part 11/Annex 11 compliant and establish a Quality Management System (QMS).

Your company can establish the appropriate framework needed to ensure compliance with applicable regulations by incorporating these results. Assurea’s team of experts can help you! We have flexible packages which can be tailored to your needs. For a more comprehensive evaluation for your company’s needs, book an appointment with us!

Recommended actions to establish a minimum set of controls to meet regulatory requirements for Part 11/ 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

Recommended actions to establish a minimum quality foundation for your QMS: 

  • Quality Manual 
  • Document Management 
  • Change Control 
  • Vendor Management
  • Incident Management 
  • Supplier Management Program
  • Data Integrity Program
  • Training