Over the years we have seen a steady increase in companies moving away from paper-based validation to electronic based approaches after the FDA introduced 21 CFR Part 11, which addresses the use and control of electronic signatures. When utilized correctly, this opens the door to numerous potential process and solution improvements in CSV, yet many teams have failed to take full advantage of these improvements. Understanding Part 11 and moving to electronic based systems is a step in the right direction, but it’s important to understand that not all variants of electronic based CSV methodologies are created equal. At the lowest rung of these variants, I present the electronic document.
The conversion from a paper document to an electronic document is a pit fall that many teams have fallen into under the false hope of making forward progress in CSV. It seems like process evolution, it seems more modern, it seems like improvement, and it somewhat is in some areas, but only barely. The reality is that the shift from a paper document to an electronic document-based approach to CSV is not nearly as much of a leap as one would hope. When distilled down, little new is being achieved other than simply moving the same paper-based process and documents to a computer screen instead of a physical piece of paper perhaps adding some templates and workflow. It’s putting a slightly modern spin on the inefficient, antiquated paper-based methodology and brings with it many of the same downsides.
To throw in a quick metaphor to color things up a bit, teams that have utilized 21 CFR Part 11 to replace the paper document with an electronic document methodology have essentially only used the prison guard’s keys to loosen their shackles for a little extra comfort instead of using them to escape from the prison altogether.
This methodology adoption should by no means be considered fully modernizing CSV processes or solutions, nor should it be considered the fullest utilization of what 21 CFR Part 11 offers. So why have so many teams opted to leverage this variant of electronic based approaches to meet their CSV requirements?
To start, moving to an electronic document-based system comes with a certain sense of familiarity and with familiarity comes comfort. Adopting the electronic document looks and feels much the same as processes that were already in place, so in theory it would not take a huge revision in SOP’s, nor would it require a large investment in retraining employees. Afterall, introducing change into a regulated environment can be a difficult task in and of itself (a topic which we will cover in more depth down the road) and an electronic document with an electronic signature feels like just enough evolution without having to introducing revolution, so the burden of positioning internal buyoff is lessened.
As an added bonus, the electronic document does remove some of the more obvious headaches of the paper-based approach by allowing for a simplified method of review and approval, document retrieval and document sharing. No more printing and signing documents, storing boxes of binders filled with validation documentation, scouring the annals of storage facilities looking for pieces of the validation puzzle at an auditor’s request, etc. Couple these (small) benefits with the power of something familiar and comfortable in a regulated environment and it becomes easy to understand the appeal.
However, these benefits are relatively insignificant in contrast to the limitations of the document, and familiarity and comfort should not be reason enough to shy away from necessary innovations. As mentioned earlier, the electronic document carries with it many of the negative characteristics and limitations of the paper document, the operative word in both methodologies being “document”. Regardless of whether it’s a piece of paper with wet signatures or a PDF with electronic signatures, the static document simply does not lend itself to modern demands on development and testing teams.
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.