For many of the medtech and pharmaceutical companies I consult with, there’s a common clash of the validation systems “worlds” raging: traditional, “this is how we’ve always done it” paper documentation versus newer, tech-driven solutions.
In order to effectively harmonize business processes company-wide, I argue that innovation is critical, as the challenge is not just to validate a system for now, but also to keep it validated far into the future.
This kind of planetary shift in corporate culture doesn’t happen overnight. The resistance that stems from legitimate concerns like compliance often overwhelms progress.
Take for example a CEO for a large clinical research company that I recently worked with. The company had a systems validation process it had been using for eight years… but they also had an entire room solely dedicated to paper documentation, where every sheet required multiple signatures, screenshots and so on. They kept the paper-stuffed room not because they were ever going to use it, but because they figured they might as well keep it.
The CEO asked me, “Is this the definition of validation? Is this what we really need for compliance?”
And I told him, “Absolutely not.”
Still, doing away with the old system, even if top leadership knows it will save time and money, doesn’t ensure easy adoption by the rest of the company. Team members may cling to the old way of doing things, because it’s comfortable, habitual and in some ways, “ain’t broke” (so don’t fix it).
In cases like this, I find the best strategy to get buy-in from team members and fight resistance to change is to hold up a mirror to allow them to see things as they truly are.
So, in that company, I then asked people in the quality department, “ Are you really writing test protocols for each individual test run in Word? And then you have to print them out and then run around to get signatures?”
“Yes, this is what we do.”
At this stage, I pointed out that 80 percent of their time is spent preparing the test protocol on paper, with only 20 percent spent on the execution. Flip flop that equation with 20 percent spent on documentation and 80 on testing, and not only is it more efficient, but also job satisfaction skyrockets, as these team members didn’t study physics to collect signatures on paper.
There are also certain times of the year that are ripe for supporting this critical shift in the organization-wide mindset. Take for instance the annual Medica show in Germany that happens each November. Every IT company wants to present its newest software release, so by August, everyone goes into overdrive trying to figure out how to hit this important milestone.
The annual mad dash can be easily solved with a solid Computer Systems Validation (CSV) process. And while it’s for the good of the company, each team member also personally benefits from being part of a successful launch and ongoing validation. Thus the battle for the hearts and minds of every person involved in the process is won by moving to paperless validation.
Because in today’s global world, innovating solutions is the best way to rocket a project — and a company — to success.
Markus Roemer will speak on the topic of a sensible and compliant approach to Computer System Validation (CSV) for Jira and Confluence at the one-day conference, “Practical Solutions in CSV and SDLC for GXP & MedDev” on 3 October in London.