For companies that are implementing a QMS from scratch, my advice would be to start immediately with an electronic QMS. It will save you so much time, effort, frustration and money in the future!
But what if you already have a paper-based QMS? And you are busy developing and improving your devices? And you have all these procedures in their nice binders (which nobody reads) and records in other binders. And the auditors seem to like it this way…
Well, ask yourself this question: What is the true purpose of a QMS? Filling binders or improving the efficiency of your organization and ensuring the quality of your product?
Most companies feel they have other things to do than to transfer their existing QMS to an electronic one. However, as they grow they also outgrow their existing QMS. After lots of hours of frustration they start looking for solutions.
But what with the next audit? Or with your 510(k) submission file that is almost ready? Or perhaps you are about to release a new version of your software product?
True…there is never a perfect moment for that switch.
However, one approach that can work is to start the switch in the back and describe in a process how you will make this transfer. Perhaps you want to do it in a phased way?
Or perhaps once the audit has passed, it’s ok to make the full switch all at once? Everything is possible, but describe your plan in a clear and realistic way.
Some things you shouldn’t forget:
- Make sure your plan allows people to keep on working with an approved version of your QMS.
- Make sure you cover what you will do with the old paper documents.
- Map the relationship between old and new document numbering, versioning method etc.
- Make sure people have access to and are being trained on the electronic system before it officially replaces the existing QMS.
- Document clearly where the paper-based QMS ended and the electronic QMS started.
- Validate your QMS software and make sure you have a process for re-validation when there are changes in the QMS software.
Even though it requires some effort, don’t forget your organization will benefit from this change.
Don’t be afraid to improve!