There’s no doubt that deviating from compliance in the face of FDA requirements can bring with it many adverse consequences. Still, that doesn’t mean that holding to legacy processes to appease those requirements is still the best way to proceed. Afterall, technology changes. Methodologies change. Failing to adapt and make use of the tools one has available to them in as effective a way possible is stifling and remaining with rudimentary e-signatures definitely comes at a cost.
As we’ve discussed in previous posts, simply adding compliant electronic signatures to a solution does not really make it a true GxP solution for Agile teams or teams focused on SDLC optimization. Basic Part 11 compliant electronic signatures on static documents offer nothing by way of managing or governing workflows across validation projects or the SDLC solutions that may be used to execute those projects.
Shortcomings will also be found in the ability to enable automatically maintaining, recording or generating traceability, mandating proper review and approval flows, and creating and capturing an audit history trail. Instead, all of this will still often have to be managed manually which comes with additional cost, effort and risk of human error.
With little control over routing, approval and traceability across an organization’s SDLC tool stack and teams, there is a lack of governed assurance that consistent processes per defined policies are being adhered to. We then also sacrifice a common user interface for validation and compliance related activities.
This lack of ability to maintain consistency, visibility and autonomy within a solution set becomes very problematic and potentially unwieldy in maintaining effective process and workflows for Agile focused teams. As we take this all into consideration, it further illustrates our concerns around human error being brought into the picture and the compliance gaps that come with that implication.
For a moment, let’s just put the human error risk aside as we know the potential consequences that comes with that from both a productivity and compliance perspective. Instead, let’s now take a look at some numbers we’ve gathered and put together after doing some polling of teams we have worked with. We’ve found that teams utilizing manual effort, supported by either basic electronic signatures or ink signatures, in conjunction with Agile solutions require an average of 35-40% additional effort when compared to a truly Agile designed and oriented GxP solution and process mix.
That is substantial to any organization and it should really make us take a step back and evaluate the efficacy of how compliance requirements are currently being achieved throughout the software development lifecycle. Further, we need to look at how that affects the investments that teams make in solutions like Jira relative to desired outcomes.
With all that in mind, are we really so sure that we can call legacy validation processes a “safer” or “more risk averse” approach at this point just because they have been used to some degree of success in the past?
From a compliance standpoint, we see increased risk of human error in many aspects. Leaving tasks like routing and executing review and approvals, record management, traceability and audit history up to largely manual processes across multiple SDLC tools and teams leaves plenty of gaps.
On the actual business efficiency and cost side, we see outdated processes and methodologies that are very disruptive to modern tools and processes. These disruptions come as a result of the lack of ability to standardize workflows and incorporate compliance activities across SDLC solutions that were designed to speed up and enhance productivity.
In reviewing all this, it seems that, at the very least, looking at other options is more than viable at this point. It’s important to maintain compliance, but it’s also important to find the right balance of process controls and solution utilization in conjunction with a more fluid and dynamic implementation of 21 CFR Part 11 compliant electronic signatures.
The good news is that many teams in regulated environments have already successfully managed to navigate down this road and have more fully been able to leverage the benefits solutions like Jira for use in their regulated projects.
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.