Adam Lawler answers the big questions about one of the life science industry’s core tenets.

The life sciences industry would be nothing without regulatory consistency and control, and one of the most significant forces governing the manufacture of pharmaceuticals is 21 CFR Part 11. The question is, what is it exactly? For such an important regulation it seems to be constantly shrouded in mystery and more than a fair share of confusion, and in this article we hope to answer the big questions about one of the industry’s core tenets.

In short, 21 CFR Part 11 is a section of the Code of Federal Regulations (CFR) which outlines the Food and Drug Administration’s (FDA) code pertaining to electronic signatures and electronic records. What does this mean? Basically, it amounts to accountability, traceability, and transparency. 21 CFR Part 11 clearly lays out the checklist for accurate electronic records and signatures, with the express intention of making sure that companies adhere to good practices when it comes to electronic data logging and maintenance, guaranteeing accuracy, mitigating potential cases of human error, and ensuring that any alterations made to an electronic document can be traced.

What counts as an electronic record? A simpler question would be what doesn’t; the definition is broad, encompassing everything from words to sound. More specifically, Part 11 defines an electronic record as “any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.” Traditional analogue methods of record-keeping are not exempt, as paper documents, when scanned into a computer, also fit under 21 CFR part 11 as soon as they are digitised.

Where did this law come from? The law originated from meetings between the FDA and pharmaceutical companies regarding how to deal with record-keeping when entering the hitherto nebulous electronic sphere. Eventually, after much refinement, 21 CFR Part 11 emerged as the proffered solution in its core version in 1997. The most significant alteration made to the law since then was in 2000, when the FDA acknowledged further-developing digitisation by officially stating the equivalence of paper records and electronic records, as well as of electronic signatures and traditional ink signatures. It should also be noted that there is a European equivalent to 21 CFR Part 11 called Annex 11, and, while extensive similarities exist, the requirements of the two do not entirely correspond, something we will explore at length in a later article.

Considering the unwieldy and outmoded nature of paper record-keeping and the ever-shifting electronic landscape, such a law could always stand to be further amended. Over the years, 21 CFR Part 11 has been supplemented by guidance documents relating to data integrity and data management practices from various bodies – including PIC/S, MHRA and WHO, as well as the FDA themselves who issued a draft guidance ‘Data Integrity & Compliance with CGMP’ in April 2016 – but as it stands, 21 CFR Part 11 is one of the longest standing and most influential laws in the life sciences industry pertaining to electronic data.

In a world without 21 CFR Part 11, the impact of human error would be much more significant, and the electronic landscape would remain an untameable beast with no guarantee of accountability or traceability. With it, navigating the overwhelming breadth of the digital realm is that much easier, the outcomes more accurate, and technology becomes just another tool in the belt of regulated record-keeping.