How paperless validation assists pharma success

Written by Rina Nir

How Paperless Validation Makes a World of Difference to Your Medtech Company Success

Why should I implement paperless validation

For many of the medtech and pharmaceutical companies I consult, there’s a common clash of the validation systems “worlds” raging. Traditional – “this is how we’ve always done it” – paper documentation. Then there’s newer, tech-driven solutions. The solutions that pursue paperless validation.

In order to effectively harmonize business processes company-wide, innovation is critical. The challenge isn’t 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.

Story time

Take for example a CEO for a large clinical research company that I recently worked with. The company had a systems validation process it’d been using for eight years… and also a room for paper documentation. There, every sheet required multiple signatures, screenshots and so on. They kept the paper-stuffed room not out of necessity, but because 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, doesn’t ensure easy adoption by the rest of the company. Team members may cling to old practices because it’s habitual and “ain’t broke” (so don’t fix it).

In cases like this, the best strategy to get buy-in from team members 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. Only 20 percent of time was spent on the execution. Turn that equation around. Spend 20 percent spent on documentation and 80 on testing. Not only is it more efficient, but also job satisfaction skyrockets as the team has an easier time collecting signatures.

Who’s making the shift?

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. 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. Not only is it for the good of the company. Each team member also personally benefits from being part of a successful launch and ongoing validation. The battle for the hearts and minds of everyone involved in the process is won by moving to paperless validation.

In today’s global world, innovating solutions is the way to rocket a project — and a company — to success.


Blog posts in this series:

  1. Digitising paper QMS & ensuring ISO-27001 compliance
  2. How we Saved a medical device company time, compliance headaches and money
  3. Painless migration from Excel

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