In any organization, regardless of industry or areas of focus, implementing change is a daunting task filled with objections, arguments, cost analysis, ROI’s and a seemingly never-ending series of heated meetings. It’s a shared story across any organization, but it becomes especially complex when evaluating the implementation of new methodologies and technologies into a regulated environment. The more significant the proposed change, the more difficult the process of making that change a reality becomes and fewer subjects will be met with more pushback than evaluating and proposing a CSV overhaul.
Introducing new methodologies to CSV is an undertaking that should not be approached lightly and there will be plenty of internal stakeholders that will be sure to make this abundantly clear. In fact, many will be very vocal or downright obstinate in their objections to shifting from the status-quo. In their arsenal, objectors will have numerous valid concerns, as well as several potential roadblocks at their disposal, so expect to hear things like…….
“If we rollout a new process and use new solutions, we’ll have to re-author all of our SOP’s. Who is going to handle that?”
“New SOP’s will mean that everyone will have to be retrained accordingly. We simply don’t have the time or resources to dedicate to something like that.”
“Quality is pretty set with their current solutions and process, and they are pretty staunch in their rigidity when it comes to how things are done. They will never sign off on this.”
“Introduce a new system into our environment? That means we’ll have a whole new validation lifecycle to account for moving forward. I don’t think we have the resources or budget to take something that that on.”
“We’ve spent years and countless hours building what we are currently using. It feels like it would be a waste to throw it all away to implement something new.”
“We will have to completely change how we handle audits. I don’t think that’s a risk we want to take.”
“Why would we change how we’re doing things now? It works.”
These are all valid items that need to be addressed, but that doesn’t mean that current solutions and processes are meeting those challenges effectively either. This is the type of pushback that has really handcuffed the Life Sciences industry. It’s why technology teams in most Life Sciences companies are generally many years behind other industries when it comes to adopting methodology and technology standards. Forget about being at the forefront of innovation and trends, I’m talking years behind widely utilized standards.
In order to overcome those objections and really introduce change and forward progress in CSV, planning and execution must be well thought out. Teams championing those changes need to first be able to identify shortcomings of current solutions and processes. They must then be prepared to demonstrate a solution that will not only address those shortcomings but will decrease risk while improving operational efficiency.
Swapping paper documents for electronic documents has marginal benefits and wrapping additional solutions around electronic documents only further complicates an already complex and risk heavy methodology. So, what addresses the flaws we’ve discussed in a document-based CSV? What can replace the document that addresses all the most common objections teams face when proposing this shift? What achieves all this while bringing your organization into the modern era of software development and quality technology standards?
The answer lies in ditching the document and moving to a more dynamic and flexible data-driven validation methodology.
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.