The autoloMATE® platform is engineered to facilitate adherence to global regulatory and accreditation standards. Through technical design and rigorous validation, our platform ensures compliance with electronic record and signature requirements mandated by the US FDA (21 CFR Part 11), the UK MHRA, and the EU EMA (Annex 11) for the advanced therapies sector.

To ensure electronic records maintain the same reliability as paper-based systems, the platform integrates four foundational pillars:

• Electronic signatures: Captures signatory names, time stamps, and formal intent (e.g., authorship or approval).

• Immutable audit trails: Employs ledger technology to generate secure, time-stamped logs of all system entries and modifications.

• Role-based access controls: Enforces role-based permissions and user-group segregation to restrict data access to authorized personnel.

• Data retrieval: Enables the generation of accurate, human-readable records (e.g., PDF) for regulatory inspection and long-term retention.