Product News

It’s so easy to comply with FDA 21 CFR regulations for electronic records and signatures

15 Feb 2022

In Title 21 of the Code of Federal Regulations, the Food and Drug Administration (FDA) regulates, among others, the requirements for the manufacture of foods, drugs, and cosmetics. Part 11 defines the exact regulations for electronic records and electronic signatures. The PPR and Legendary^TM have been designed to meet all technical and system requirements of Part 11 from the beginning.

Paperless Process Recorder (PPR) is a digital recorder system which avoids many mechanical issues of traditional paper chart recorders for process monitoring. Legendary^TM is a cloud-based software solution to record, manage, approve, store, and transmit the process records made by PPR in an electronic manner.

To comply with all legislative regulations the FDA set up a guidance for the Food and Drug industry under CFR Title 21 Part 11 “Electronic Records; Electronic Signatures – Scope and Applications”. This document provides guidance to persons who, in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA, have chosen to maintain the records or submit designated information electronically and, as a result, have become subject to part 11. Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations (FDA website).

The digital data management with PPR and Legendary^TM makes process recording easier, but for internal documentation and workflows the specific regulations have to be known and respected. In addition to prior regulatory charting requirements, Part 11 becomes applicable in certain PPR & Legendary applications due to the electronic records created by PPR and the signatures that are generated though PPR and Legendary™.

For users of the PPR and Legendary^TM Solution Anderson-Negele has created a special application guide. This document provides guidance how the system itself complies with the regulations, and how the client can easily validate compliance to FDA 21 CFR Part 11 in their recording application. It provides assistance to the adaptation of internal processes and security in dealing with the FDA Regulations for all people in charge of the processes or involved in their execution.

Click here to download the FDA 21 CFR Part 11 Application Guide.

If you have any questions regarding PPR and Legendary™ or are interested in a demonstration of the advantages of the new digital process monitoring systems, contact us at PPR-LD-AE@Anderson-Negele.com.