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.