Compliance to FDA 21 CFR Part 11 Requirements

Whitepaper | March, 2020

Some industrial segments need to be exponentially stringent with their quality and compliance processes compared to other segments. The Life Science industry is part of this stringent segment. They need to ensure the quality of their products because they deal with human safety. The accuracy and efficiency of their work could well be a matter of life and death. This whitepaper documents ComplianceQuest’s position regarding compliance to Electronic Records; Electronic Signatures 21 CFR Part 11. We have provided detailed answers to the sub-part B Electronic Records and sub-part C Electronic Signatures in an easy to read tabular format. Read this whitepaper to evaluate how ComplianceQuest’s 100% cloud-based EQMS system would meet your quality and compliance needs.

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