Introduction to 21 CFR Part 11 and Related Regulations

DeRose, James; Barbero, David R.

June 30, 2021 Story

Introduction to 21 CFR Part 11 and Related Regulations

Medical Device Industry Quality Control

This article provides an overview of regulations and guidelines for electronic records (data entry, storage, signatures, and approvals) used in the USA (21 CFR Part 11), EU (GMP Annex 11), and China (NMPA) which affect digital inspection approaches for the quality control of medical devices.

Authors

¹Leica Microsystems

Key Learnings

Recommendations and requirements from regulations and guidelines for electronic records and signatures concerning quality control of medical devices.

Overview of regulations and guidelines for the USA, EU, and China
How the regulations and guidelines are similar and different
Current digital inspection methods and challenges meeting regulations for electronic records

For the medical device industry, you can establish a digitally enhanced inspection solution for more efficient quality control and be ready for electronic record regulations with the help of Exalta, a smart device for traceable microscopy.

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Find out more about the regulations and guidelines for electronic records related to documentation and reporting for quality control of medical devices. Please fill in the form below to receive the full article.

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