Compliance with 21 CFR Part 11 – Electronic Record Electronic Signature enabled supply chain execution for Medical Device and Drug companies

By March 15, 2021 March 22nd, 2021 WhitePaper

Anyone working in manufacturing and distribution of medical devices and drugs is well versed with the ‘21 CFR Part 11’ requirements. In 1997, US Food and Drug Administration (FDA) issued regulation popularly known as “21 CFR Part 11”. The regulation aims to assure that computerized records are safe, accurate and secure. As per the regulations, the software application’s role is to ensure that the data pertaining to manufactured goods is electronically captured, manipulated, extracted and coded during the manufacturing of the product.


About the Author

Shantanu Bedekar is experienced ERP professional. He has experience working with diverse domains from Industrial to Medical Device Manufacturing across the globe. His area of expertise is supply chain execution, supply chain planning and costing. Shantanu is a PMP certified professional. His educational background is Engineering and MBA in operations management.

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