White Paper: Application Of Electronic Records & Signatures In Calibration Management Software
•White Paper: Application Of Electronic Records & Signatures In Calibration Management Software
Effective August 20, 1997, the Food and Drug Administration (FDA) issued 21 CFR Part 11, setting forth criteria under which the agency will accept, under certain circumstances, electronic records and electronic signatures as equivalent to paper records and handwritten signatures. Part 11 allows firms to take advantage of electronic technology, and to have electronic records considered equivalent to traditional paper records.
Such systems will need to be validated to ensure accuracy, reliability, and consistency, and they will need security checks and audit trails to verify that records are accurate and that changes are recorded. Electronic signatures are subject to additional requirements, to ensure that a signature can only be used by its genuine owner, and that the act of signing a document electronically is equivalent to a traditional handwritten signature.
Calibration Management Software (CMS) is database software designed specifically to help companies meet the calibration record-keeping requirements of 21 CFR Parts 211 and 820. Many Commercial Off The Shelf (COTS) software packages are available. The features and specifications of CMS that help ensure compliance with Parts 211 and 820 will also simplify compliance with Part 11. These features include password-based security and time-stamped audit trails. In addition, the software should include an Electronic Signature feature designed to help meet the requirements set forth in Part 11.
The cGMP's state in numerous instances that records of calibration and maintenance information must be maintained, and these records are subject to document controls that include, among other things, signatures of the reviewing or approving party.
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•White Paper: Application Of Electronic Records & Signatures In Calibration Management Software