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FDA 21 CFR Part 11: An Introduction

Understanding FDA 21 CFR Part 11

Title 21 CFR Part 11 establishes the United States’ Food and Drug Administration’s (FDA) regulations concerning the use electronic records and electronic signatures in FDA regulated industries. As such, the regulations, generally speaking, apply to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated organizations.

Lab personal signing

Historically, laboratory records were kept in paper, hardcopy form and bore handwritten signatures attesting to the data’s origin and validity. Although it is possible to forge a handwritten signature, handwritten signatures are generally considered to be highly reliable. Perhaps most importantly, it is difficult to refute a document bearing one’s handwritten signature – an important concept called irrefutability. In addition, short of destroying the documents completely, any attempts to change the data or signatures can usually be detected easily.

As more laboratory instruments produce electronic data and more organizations wish to enjoy the efficiencies of storing and sharing information electronically, the challenge becomes how to ensure the same level of reliability for electronic records that is provided by paper records. By their very nature, electronic records are easy to change, both deliberately and accidentally.

Dealing with digital images is particularly challenging. The notion of “photoshopping” images is widespread. A subtle change in contrast, for example, could make important evidence in an image disappear, or it could, beneficially, make it more apparent. Therefore, especially when dealing with images, it is important to know who did what when and to be able to revert to the original data.

CFR 21 Part 11 sets out the FDA’s requirements for handling electronic records in an acceptable manner. Highlights of the regulations with respect to electronic records and electronic signatures include:

Storing laboratory data as electronic records can lead to great improvements to efficiency in your organization. Because electronic records can be backed-up, it is possible to achieve even greater reliability than with paper records, which are subject to physical damage and deterioration. However, care must be taken to use software and systems, such as Quartz PCI/CFR, that help you comply with the FDA’s 21 CFR Part 11 regulations.

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