21 CFR Part 11 Electronic Records & Signatures Checklist

Implementing a new LIMS and unsure where to get started?

The FDA’s, Code of Federal Regulations (CFR), 21 CFR part 11, specifically outlines the criteria for electronic records and signatures.

When it comes to remaining compliant with the FDA's 21 CFR part 11, use our easy-to-use checklist to help you get started on creating a LIMS User Requirements Document. The document is a summary of regulations that should be considered when defining User Requirements, whether you are newly implementing a LIMS or replacing your current LIMS.

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