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Why 21 CFR Part 11 can be implemented sensibly

posted 25 Sept 2015, 05:21 by John O'Sullivan
First published on LinkedIn 16th Sep 2015

The Code of Federal Regulations is the codification of the rules and regulations issued by the US Federal Government. There are 50 titles and they cover all aspects of federal law. For example Agriculture, Energy, National Defence, Public Health etc.

Title 21 is Food and Drugs and is administered by the Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA). Chapter 1 falls under the remit of the FDA and is further broken down into Food, Pharmaceuticals, Medical Devices, Animal feed and medicines as well as Radiography and Mammography. These sectors are generally gathered under the term Life Sciences. Part 11 covers the guidelines on Electronic Records and Electronic Signatures related to the Life Science industry.

One may wonder why an indigenous Irish company operating in the Irish market has to concern itself with this US regulatory document. As an open economy, Ireland depends on Foreign Direct Investment and as a result most large manufacturing plants in this country export to the United States. This is particularly true of the Life Science industry. Any company exporting to the US is subject to regulatory oversight and audit by the FDA and failure to comply can result in warnings, non-conformance reports and even plant closure.

Douglas supplies control and automation systems which include databases of information which constitute batch records. These batch records form part of the traceable data associated with the product/device. If there is a problem with a product in field, this data has to be available. It can outline, where a product was manufactured, when and by whom. Audit trails can identify the staff on duty during the manufacture, process parameters used, logs of alarms and events related to the batch as well as trends of the temperatures, pressures etc. of all critical instruments. Other information systems (LIMS, MES, ERP) can also provide lists of the raw materials, laboratory results, shipping details and distribution channels but this is outside the scope of this essay.

If a company has decided that electronic records rather than paper records constitute the batch record, then the data has to be recorded, logged and stored in compliance with Part 11. It instructs that procedures and systems are in place to ensure the authenticity, integrity and confidentiality of the records.

When 21 CFR Part 11 was published in 1997 it was considered excessive by user groups. This was due to misunderstanding of the requirements and the lack of Commercial Off The Shelf (COTS) software solutions to help implement it. As a result, some companies continued to use paper records (with the associated overhead of review, storage, security etc.), others implemented expensive bespoke software solutions (with the risk of obsolescence and lack of future support).

In 2001 the FDA issued a guidance for industry narrowing the scope of Part 11 and elaborating on the use of paper records produced from a computer system.

In general, with common practice among manufacturers & suppliers and the release of “21 CFR Part 11 compliant“ COTS software from the major vendors, it has become relatively straightforward to implement a compliant solution.

In conclusion, as with the Risk Based approach in GAMP5, Part 11 compliance depends on a sensible, collaborative approach where data integrity and hence product quality and patient safety can be ensured in cost effective manner.