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GyrusAim LMS offers secure 21 CFR Part 11 compliance, ensuring alignment with FDA regulations on electronic records and signatures. Features include electronic signatures, course versioning, auditing capabilities, and robust data security measures, essential for regulatory compliance in industries like pharmaceuticals and medical device manufacturing.
Comprehensive audit trail tracking changes to ensure regulatory compliance. Access to transparent records of actions, including timestamps, user IDs, and the nature of changes, ensuring accountability and traceability for internal reviews or external audits.
Electronic signatures, when used in conjunction with PINs, ensure the integrity of electronic records. Ensures that once an entry is made and signed, it cannot be changed without leaving an audit trail.
Electronic signatures combined with PINs help verify the identity of the user who is signing a document or logging into the LMS. This ensures that the person accessing the system or signing records is authorized to do so, providing a secure layer of authentication.
All course versions must be tracked so that updates can be communicated to users. Accurate version control and historical content access are critical requirements for compliance with 21 CFR Part 11.
Authorized personnel have continuous access to training records, enabling swift data retrieval as needed for audits or inspections, and ensuring compliance with accessibility requirements under 21 CFR Part 11.
GyrusAim LMS undergoes extensive validation processes, including over 130 QA steps. This confirms its compatibility with FDA-regulated organizations and compliance with technical standards outlined in 21 CFR Part 11.
