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 - How we can help with 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.

Read More

CHOSEN BY THESE CUSTOMERS...

Almac - How we can help with FDA 21 CFR Part 11Baxter Logo 2 - How we can help with FDA 21 CFR Part 11BD logo - How we can help with FDA 21 CFR Part 11logo1 - How we can help with FDA 21 CFR Part 11logo2 - How we can help with FDA 21 CFR Part 11Bristol Myers Squibb 2020 - How we can help with FDA 21 CFR Part 11CSL Behring - How we can help with FDA 21 CFR Part 11Depuy Synthes - How we can help with FDA 21 CFR Part 11Dentsply - How we can help with FDA 21 CFR Part 11getinge logo rgb 3000px - How we can help with FDA 21 CFR Part 11Intuitive - How we can help with FDA 21 CFR Part 11Ivoclar Vivadent - How we can help with FDA 21 CFR Part 11Janssen logo - How we can help with FDA 21 CFR Part 11Johnson Johnson 1 - How we can help with FDA 21 CFR Part 11Leica Biosystems - How we can help with FDA 21 CFR Part 11Medtronic - How we can help with FDA 21 CFR Part 11Nox Medical logo 1 - How we can help with FDA 21 CFR Part 11OriGen Biomedical - How we can help with FDA 21 CFR Part 11PCI 1 - How we can help with FDA 21 CFR Part 11Parexel - How we can help with FDA 21 CFR Part 11Pfizer - How we can help with FDA 21 CFR Part 11Phadia - How we can help with FDA 21 CFR Part 11Piramal Healthcare - How we can help with FDA 21 CFR Part 11Sharp - How we can help with FDA 21 CFR Part 11Teva - How we can help with FDA 21 CFR Part 11UCB logo - How we can help with FDA 21 CFR Part 11Smith and Newphew 1 - How we can help with FDA 21 CFR Part 11Smiths Medical 1 - How we can help with FDA 21 CFR Part 11Stryker 1 - How we can help with FDA 21 CFR Part 11ThermoFisher Scientific 1 - How we can help with FDA 21 CFR Part 11Zimmer 1 - How we can help with FDA 21 CFR Part 11Allergan Logo - How we can help with FDA 21 CFR Part 11