GxP Track℠ helps you meet every requirement of 21 CFR Part 11. No complex integrations. No custom code. No manual logging.
21 CFR Part 11 is a set of FDA regulations that govern how electronic records and electronic signatures must be managed in regulated industries. The goal is to ensure digital data is just as trustworthy and audit ready as paper records. Key requirements include:
Access must be controlled & traceable.
Data must be tamper-evident & verifiable.
Every change or action must be logged under a verified user.
Digital sign-offs must be legally equivalent to handwritten ones.
Complying with Part 11 is essential for passing inspections, maintaining product quality, and avoiding fines or delays.
Trying to meet 21 CFR Part 11 requirements without software is risky. Manual logs, loose permissions, and fragmented data make it almost impossible to:
That's why the FDA expects robust digital controls. And, why the right platform matters.
Our platform meets or exceeds every technical requirement. No middleware. No custom dev. No gaps.
All actions & records are tied to a verified user identity using TLS client certificates & cannot be modified post-capture. Every log is timestamped & stored immutably.
GxP Track℠ requires certificate-based identity validation & timestamped, non-editable records to ensure sign-off intent & prevent repudiation.
Our platform is containerized & modular, making it easy to validate individual components. We provide documentation & tools to support validation workflows.
GxP Track℠ logs role-based user activity & links training completion to protocol changes. All training & role assignment actions are recorded with audit-ready metadata.
Version-controlled documents, approval workflows, & change logs are all captured automatically with timestamps & user identity, ensuring full traceability.
GxP Track℠ captures digital signatures with name, timestamp, role, & intent of action. All elements are stored together in an immutable audit trail.
Every digital signature is automatically & permanently linked to the associated action or document, ensuring traceability and legal defensibility.
Get a demo of how GxP Track℠ simplifies 21 CFR Part 11 organizational data compliance - without adding friction to your workflows.
See how GxP Track℠'s patented container architecture can streamline your quality management and reduce audit preparation time.