April 6, 2023

Is that eQMS platform (such as SharePoint) fit for its purpose?

I saw a question today wondering whether SharePoint is suitable for maintaining a medical device QMS documents system and record control. In a nutshell, SharePoint (or whatever other eQMS practice is proposed) may or may not be suitable for maintaining the QMS documents system and record control, or for other QMS operations, depending on the case.  Here are some key points to consider when figuring out whether a computer platform is suitable for QMS purposes:

• ISO 13485:2016 (as amended; hereinafter “ISO 13485”) is intended (clause 0.1) to allow flexibility, rather than mandated uniformity, in the structure of different quality management systems.  Accordingly, ISO 13485 doesn’t out right prohibit the use of SharePoint, nor any other eQMS solution, to facilitate QMS operations.

• ISO 13485 doesn’t really allow anyone to just “believe” that an eQMS approach is unfit.  Instead, we are expected to employ an impartial scientific method whereby we validate the software for its defined intended use per clause 7.5.6, fourth paragraph.  If the software fails that process, only then can we conclude it is unfit for its purpose.  Don’t be tempted to assert unfitness apart from that impartial scientific method.

• The U.S. FDA’s eQMS software validation requirements [21 CFR §820.70(i)] reflect the same principles as described above for ISO 13485.