Quality Management Software for GMP Critical Electronic Records

Traditionally, records that are required for compliance with GLP, GCP and GMP or that will be submitted to regulatory authorities have been maintained on paper and, where required, authorized through the use of a hand-written signature on that paper.

Modern automated systems allow us to perform record-keeping functions through the use of computerized systems, which may replace the paper records entirely or in part.

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Electronic Batch Record Design Considerations

In addition, it is possible to add an electronic signature to those records that serves the same purpose, has the same meaning and the same legal significance as a hand-written signature.

Since these records and signatures are critical to both compliance and other business needs, it is important that processes and controls exist to ensure their integrity, security, and appropriate confidentiality. The use of electronic records and signatures is voluntary and so it is still permissible to use manual record-keeping systems and sign records on paper using traditional controls, although this may in many cases be considered cumbersome and less cost-effective.

Wherever it is practicable, new systems that employ electronic records or signatures should not be implemented until full compliance is achieved. It is recognized that where commercial off-the-shelf software is purchased, even where it is best available for purpose, it may still be some time before a fully compliant version is available.

In these situations the gap between the system as it stands and a state of compliance must be analyzed and the associated risks assessed. An action plan, approved by local management and reviewed or approved as appropriate by QA, should be developed to include any operating procedures or other stop-gap measures which can be employed to manage the risks from non-compliance and the proposed steps to ultimately achieve compliance.