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21CFR Part 11

The enforcement policy of the US FDA to accept electronic records, 21CFR PART 11, has triggered a great need for all open systems to be converted to closed systems for compliance. Caliber LIMS is designed to work in a regulatory regime, with its high compliance to stringent regulations on electronic documents and electronic signatures (US FDA’s 21 CFR Part 11 norms). Caliber LIMS fully complies with 21CFR PART 11. All the required security is provided to link the electronic signature to the applicable record. All the audit trails related to the records are well maintained and authenticated to make the electronic records authentic and tamperproof. Application security is highly configurable to set the password length duration, role based authorization. Caliber LIMS focuses on traceability and identifying accountability throughout the product life cycle.

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