How we can help with FDA 21 CFR Part 11

How we can help with FDA 21 CFR Part 11

FDA 21 CFR Part 11 allows life science organizations to use electronic records and signatures in place of paper... but only using it, will not mean you are compliant.

For organizations in FDA-governed industries, FDA 21 CFR Part 11 plays an important role in reducing the burden of a paper-based process, helping your organization to reduce the cost of managing and documenting your entire labeling lifecycle. But with this, comes the challenge of not only remaining compliant but documenting your adherence too.

PRISYM 360 Label Management Software provides your organizations with complete label integrity and was designed specifically to meet the strictest compliance requirements set out by the FDA. We support our customers with highly efficient software and documentation for all aspects of compliance - from FDA 21 CFR Part 11, audit logs, approval workflows, language and phrase controls, print inspection, and versions control to regulatory rules and security.

  • Software supplied as a validatable package.
  • Complete and accurate records.
  • Audit logs that go back over 5 years.
FDA Compliance whitepaper 1 - Ensuring FDA Compliance: The Essential Guide to FDA 21 CFR Part 11 Ensuring FDA Compliance: The Essential Guide to FDA 21 CFR Part 11 Posted in: Achieving Regulatory Compliance, Medical Device, Operations & Labeling, Regulatory & Compliance, Whitepaper -

FDA 21 CFR Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place of paper. This helps organizations reduce the cost of managing and documenting their entire labeling lifecycle, from routing and approval workflow, version control and comparison, to audit trails and reports.

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