September 28, 2022
Report
Ensuring FDA Compliance: The Essential Guide to FDA 21 CFR Part 11
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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.
Wondering how to get started on the path to compliance? A good first step is to read our “Ensuring FDA Compliance: The Essential Guide to FDA 21 CFR Part 11” whitepaper. In this paper, we discuss the eight phases of FDA 21 CFR Part 11 compliance and what it means to the labeling lifecycle.
- Regulatory
- FDA
- Labeling