The last thing that lends itself well to an Agile team is the document-based processes governing CSV that were born of the days when manual testing was prevalent, and a Waterfall approach was the industry standard. Even under those circumstances, document-centric CSV still proved to be (at best) a hindrance to efficient development, test and release requirements, but at least the document supported the format of the methodology of that time.
Unfortunately, this is what a lot of teams inherited and continue to use to this day, and it’s really preventing forward progress in Life Sciences when it comes to catching up to modern technology and methodology standards. Worse yet, many teams have been reluctant to explore new options to pivot from this document heavy approach and instead opt to stick with it because “it works”.
Slight adjustments may have been made in moving from paper to electronic documents with electronic signatures, but simply enabling electronic signatures on electronic documents isn’t enough to fully adapt.
Yes, adding an electronic signature solution to a tool set allows compliant signatures to be applied to large collections of data and it removes the need for physical pieces of paper, but it won’t necessarily provide the workflow governance that operates within the desired framework of Agile oriented tools, like Jira. Nor will it capture the traceability of review and approval tasks or audit history trail associated with validation elements. Instead, these bare bones signature solutions generally do little more than enable the perpetuation of outdated processes in the face of modern requirements.
So why hasn’t modernizing CSV and shifting from the document become more prevalent as Agile and DevOps have more than become the governing force behind methodologies and solution development? Why are so many teams still just using 21 CFR Part 11 in its most rudimentary form (applied to traditional validation documents)? If fully understanding 21 CFR Part 11 and leveraging it to its fullest capacity has the ability to offer software teams in regulated environments to truly achieve Agile and utilize a fully GxP ready Agile solution, why is the document still so heavily utilized?
The truth is that the document-based approach is a proven commodity and has a track record of “working”. Risk is a very real thing that teams must account for when operating in a regulated environment, and FDA regulations require that stringent compliance procedures be defined, adhered to and documented. Failure to do so comes with potentially severe consequences.
Unfortunately, the potential risk of those consequences coupled with overly complex interpretations of appeasing FDA regulations has kept teams married to antiquated processes that do not mesh with the methodology and technology landscape of today.
Check out a webinar we did on enabling Jira for Agile GxP here.
Jason Secola is the Support Sales Manager at Tx3 Services and has been with the company since 2016. Jason began working with the larger portion of the existing Tx3 team dating back to 2007 when he got his first start in the world of application testing and later began a focus on testing in a regulated environment.
He currently resides near Sacramento, CA.