The Challenge: A paper-based QMS
The SaMD company started out using a paper-based QMS. Not only was a paper QMS out of step for an organization that specializes in cutting-edge digital health products, it was deeply inefficient and led to preventable findings during audits.
The team was also concerned about tracking their employee training, which had to be tracked manually in their paper QMS. Keeping track of who had completed training modules (and when) was time-consuming and inefficient.
On top of all that was the cost—the company also had to pay for the physical storage of their ever-growing QMS documentation.
Something had to change, so they turned to Greenlight Guru.
The Solution: Greenlight Guru’s modern QMS solution
The team needed a better way to review, approve, and archive reports and documentation. They needed a way to track training within their QMS that wasn’t a massive headache. And they needed a fully traceable QMS that would help keep them audit-ready and reduce findings.
Fortunately, Greenlight Guru’s eQMS solution does all of that and more.
The Results: Improved efficiency, better compliance, and reduced costs
The organization noticed the benefits of Greenlight Guru right away.
“Because Greenlight Guru’s QMS came pre-validated, we were able to save about 60-70% of the time that we otherwise would have spent setting up a new QMS,” said the organization’s QA Professional.
And once the QMS was up and running, the differences between the old paper system and Greenlight Guru were hard to miss.
Traceability eliminates the high costs of inefficiency
“It’s made it quite a bit easier to track product changes, with everything being linked in the system. The traceability has made it a lot easier to show compliance. It’s definitely reduced the time we spent on managing documentation by at least one full-time employee,” said an organization employee. And that’s on top of eliminating the cost of storing all their paper records.
Not only that, but Greenlight Guru has completely changed the way they track training.
“Training is more compliant and better documented now. Prior to Greenlight Guru, we were tracking training manually, whereas now all training completion is documented in the system.”
A 30% reduction in audit preparation time
The ease with which documents can now be retrieved and reviewed, and the full traceability of all product changes, makes it easy for the growing team to find and prepare the needed audit documentation.
According to a QA team member, “We’ve probably saved 30% of the time we used to spend on audit prep, and now we have better outcomes. We see fewer findings and fewer follow-up items since we’ve started using Greenlight Guru.”
That means less time spent addressing issues with their QMS and more time spent building life-changing software.