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FDA 21 CFR Part 11 Compliance Guide

If your lab or company is subjected to the FDA regulations and is required to submit these records to the FDA, it must comply with specifications outlined in the Code of Federal Regulations Title 21: Food and Drugs PART 11 – Electronic Records; Electronic Signatures (21 CFR Part 11).

In this guide, you will find information about:

  • Technical requirements that an ELN needs to meet to ensure your organization can be compliant with 21 CFR Part 11

  • SciNote technical features that meet such requirements

  • SciNote’s compliance matrix with 21 CFR Part 11

Related: GMP and GLP Guide (PDF download)