We live in a time of rapid change and information overload. It helps to pause and ponder the state of things once in a while. In the software industry, the agile principles call for regular evaluation to sustain constant development. In the quality field, the concept of continuous improvement is embedded in the quality management system (QMS) as a never-ending cycle of changes based on reviews and audits.
Life science companies face enormous scientific, economic, and regulatory challenges during development of medical products. The watershed regulation, 21 CFR Part 11, established the criteria for the use of electronic records and electronic signatures by organizations under the jurisdiction of the U.S. Food and Drug Administration (FDA). Part 11 was controversial from the start. Critics complained it was too broad and confusing. Companies said it was too costly to implement. Part 11 went into effect in August 1997, but it took the FDA two guidance’s (in 2001 and 2003) to explain the regulation’s scope and application. The 2003 guidance signaled that, at last, the FDA had embraced technology for compliance purposes. It served as a catalyst for software companies to develop compliance solutions tailored to Part 11 and for the industry to automate quality processes. It’s no coincidence that in 2004, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued the SAFE (Signatures and Authentication for Everyone) digital signature standard.
Which came first, the chicken or the egg? This dilemma applies to automation and regulatory compliance. Did the FDA issue 21 CFR Part 11 to encourage technology use? Or did life science companies use technology first, which in turn prompted the FDA to develop corresponding regulations? It’s the latter, according to an article published in ISSA Journal. “In the days of old, pharmaceutical companies would literally ship truckloads of data to the FDA,” wrote Ben Rothke.
“There clearly had to be a better, faster, cheaper, and easier way to move data. And indeed there was—via electronic networks.” A group of pharmaceutical companies met with the FDA in the early 1990s to find out how they could submit voluminous documents electronically. This eventually led to the development of 21 CFR Part 11.
It’s true that regulatory requirements impose a heavy documentation burden on life science companies—a compelling reason to automate quality management system and compliance processes and regulatory submissions.
The FDA issued the rule to establish criteria for the use of electronic records and electronic signatures by organizations that comply with the Food, Drug, and Cosmetic Act, the Public Health Service Act, and other FDA regulations. It applies to organizations under the agency’s jurisdiction, such as pharmaceutical, medical device, biotech, blood, and biologics companies, and contract research organizations. It took effect on August 20, 1997.
Part 11’s overall goal is to allow the use of electronic records as much as possible and at the same time ensure public safety. In complying with Part 11, it’s important to remember the essence of the regulation—FDA’s main concern is to safeguard record integrity in order to ensure product quality.