Industrial Grade Dat Security and Compliance
we understand each factory is unique and need a unique storage system and ability transfer of data. We are committed to providing fully-compliant manufacturing software and educating manufacturers on best-practices and risk factors to avoid non-compliance in the midst of a vast and stringent regulatory landscape.
FDA 21 CFR Part 11 or EU GMP Annex 11
If you need a solution compliant with FDA 21 CFR Part 11 (or EU GMP Annex 11) you have come to the right place. Axia provides you with the below capabilities:
- Make your processes fully traceable with electronic audit trail. Create electronic signatures and quality forms for compliance
- Granular electronic workflows and access controls to ensure only authorised personnel can perform specific actions such as approvals
- Ability to control & monitor Installation Qualification (IQ) and Operational Qualification (OQ)
- Device History Records (DHR) with unique batch identification, lot traceability, and production records