Achieving compliance with 21 CFR Part 11

Pharmaceutical, medical device, biotechnology and services companies are challenged to ensure regulatory compliance through all their operations. A critical success factor is in their ability to have a common enterprise-wide solution for capturing out-of-spec/non conformance, tracking and managing the corrective action process, ensuring that the recommendations are implemented successfully and providing visibility into the process and performance metrics at various operational and management levels.

In August 1997 the Food and Drug Administration (FDA) passed Part 11 of Title 21 of the Code of Federal Regulations and established standards for the use of electronic records and signatures as an equivalent and/ or substitute for paper records and handwritten signatures executed on paper. Part 11 applies to all areas governed by the FDA and includes the pharmaceutical, medical devices, and biotechnology sectors, and extends to all records in electronic form. It is applicable to records identified in predicate rules-previously published regulations such as Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).

As illustrated in figure 1, the rule was designed to ensure that information is accurate, trustworthy, and traceable across the multiple systems and entities that fall within the FDA program areas. Most importantly, the legislation was not intended to be just another exercise in regulatory compliance. Instead, it was designed to enable both the FDA and the Life Science industry to take advantage of new technologies to improve efficiency and speed in both operations and also regulatory process and to incorporate electronic document control and change management technology into their current business processes. By establishing tight user-authentication and security, enabling audit trails, and enforcing records retention, pharmaceutical companies could realize the full benefits of electronic record and signature while remaining fully complaint.

(Source - CGEY, 2002)
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As illustrated in figure 2, Part 11 affects the entire value chain and is more pervasive on some applications in key segments of the value chain than in other. For some applications such as Clinical Data Management, Quality Management or Manufacturing Execution Systems, Part 11 influences every element of the application. For other applications such as ERP, CRM, or Training Management Systems, Part 11 impact only selected workflows and data elements. In addition, the use of good data management techniques and well constructed standard operating procedures (SOPs) can ensure that many applications which should not contain a data of record for regulatory purposes do not inadvertently become subject to the requirements of 21 CFR Part 11. Non-compliance in some application is more likely to trigger an enforcement action than others. Which applications are more important, within a specific organization, depends on how the data is used, prior regulatory history, and recent enforcement trends.

(Source - CGEY, 2002)
Please click on image for enhanced version

MetricStream's best-of-breed Enterprise Quality and FDA Compliance solutions help life sciences companies implement quality management, non-conformance tracking, corrective action and change control throughout the enterprise. If you would like to get more information on a software solution that enables you to be compliant with CFR Part 11, click here.

Please send feedback on this paper or ideas for additional research topics to the author at agupta@metricstream.com