Anyone that is part of an industry that is regulated by The Food and Drug Administration is very familiar with CFR-21, Part 11 compliance requirements. These include drug makers, medical device manufacturers, biotech companies, biologics developers, CROS and others.
CFR-21, Part 11 is a regulation set forth by the FDA that must be followed in regards to electronic records and electronic signatures. More specifically, it requires companies to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data. GAMP5 (Good Automated Manufacturing Practice) is a validation method for CFR-21. It is essentially a set of document management requirements to ensure patient safety, product quality and data integrity in manufacturing.
There has been a strong focus on data integrity generated in regulated quality control laboratories since the Able Laboratories and Leiner Health Products fraud cases in 2005 and 2006. One major compliance issue stemmed from the fact that paper copies of records differed, sometimes radically, from the electronic records maintained in the data system. The FDA revealed massive record falsification and mismanagement in an effort to avoid detection of several defective medications. In the Leiner Health case, they pleaded guilty to giving a false appearance that a batch of drugs had passed quality tests and allowed the nonconforming drugs to be shipped to customers.
The consequences can be dire for companies who fail to comply. Overcoming the challenges of data integrity is a high priority for many companies, and it is crucial to use a system that will maintain compliance requirements in the most effective way.
Find out how by reading out free white paper on how Microsoft SharePoint offers easy, effective solutions to CFR-21, Part 11 and GAMP5 requirements.
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