Quick Guide to 21 CFR Part 11
Essential knowledge for life sciences manufacturers
As a life sciences manufacturer, navigating complex FDA regulatory requirements can be challenging. This quick guide offers a concise overview of the critical aspects you need to know to meet 21 CFR Part 11 guidelines. It also explains how modern digital tools can help you achieve compliance more efficiently and effectively.
This guide covers:
Key elements and criteria of 21 CFR Part 11 compliance specific to life sciences manufacturing.
How proven digital quality management and manufacturing tools streamline compliance for your production processes.
The impact of 21 CFR Part 11 on your manufacturing operations and the benefits of efficient compliance.
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Key 21 CFR Part 11 Requirements
Staying ahead of the compliance curve requires an understanding of 21 CFR Part 11 guidelines. The following are some of the basic elements of 21 CFR Part 11 for which criteria have been established.
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Electronic Records
FDA 21 CFR Part 11 defines what electronic records are and establishes requirements for how to create, maintain, and archive them. It emphasizes the need to ensure that electronic records are accurate, legible, and retrievable throughout their retention period.
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Electronic Signatures
“E-signatures” authenticate electronic records, and 21 CFR Part 11 compliance requires them to be unique to the individual, securely managed, and linked to corresponding records. Their criteria are outlined in FDA 21 CFR Part 11.
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Electronic Audit Trails
Audit trails track changes made to electronic records, allowing for a thorough view of a record's history, including when and by whom changes were made. 21 CFR Part 11 compliance calls for companies to implement secure, computer-generated audit trails.
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User Authentication and Authorization
21 CFR Part 11 requires companies to establish procedures to ensure that only authorized individuals can access electronic records and create, modify, or approve them.
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