Problems with MasterControl in a Regulated Enviroment‏

MasterControl Hello good people of the world! Today’s post is about a software solution marketed to Pharma/biotech/med device companies. I’ve used MasterControl’s electronic Document Management System (eDMS) / Quality Management System (QMS) software at two separate operating companies now and think I have a pretty good idea of its capabilities and limitations. Bottom line is I would not recommend MasterControl as a software solution, especially in a regulated environment. These are some of the reasons why:

  • There is no way to port configuration from Development/Validation servers to Production servers without overwriting transactional data

This to me is the biggest problem with the software, and the biggest threat to compliance. What it means is the first time you do configuration you can port the entire Dev/Val database to Prod no problem, but any subsequent configuration will have to be performed manually in both Dev/Val and Prod, pretty much ensuring there will be errors in Prod.

  • “Configuration” of QMS forms includes html code modifications

See the below excerpt from the instruction manual on new solution package (i.e. QMS module) installation. The post-installation configuration includes modifications to HTML code, certainly adding regulatory risk.

HTML

  • The audit trail feature is very difficult to use and probably not 21CFR11 compliant

See the below audit trail report. It includes values that are meaningless to any human looking at it.

Audit Trail

  • The e-signature mechanics are questionable

When I first met with the MasterControl Quality representative, I was surprised to find out that his/MasterControl’s interpretation of 21CFR11’s electronic signature requirement was that the e-sig had to be comprised of two parts, both unique and kept secret, instead of the standard two parts, one being the user login. Thankfully the system allows for the common interpretation, but I was certainly left questioning the suitability of MasterControl in a GxP environment.

  • Browser compatibility leaves much to be desired

After purchase/installation at the last company I worked for, we learned that the version of MasterControl we had (which was the latest at the time) was not compatible with the latest version (11) of Internet Explorer. We knew going in that MasterControl would not be supported on alternative browsers like FireFox and Chrome, but to require us to use an earlier version of Internet Explorer was asking us to assume the known security risks that got plugged in later versions.

  • Hard-returns are removed from some fields, without warning the user. You’ll end up with stuff like this:

MasterControl Comments

  • Another example of how the interface is not user-centric/intuitive:

Forms are labeled “HTML,” which clearly has no meaning to anyone but software programmers. Makes me wonder if MasterControl has any user interface designers at all.

HTML Form

  • Unhandled error when attempting to upload an attachment above a certain size to an InfoCard:

Unhandled Error

Obviously there should be no unhandled errors in commercial-grade enterprise software.

  • There is no standard interface for external users. A real issue when some of your documentation is authored by 3rd parties/vendors.

What has been your experience with MasterControl? What eDMS/QMS solutions do you like/not like? Like this MWV (Mike Williamson Validation) post? Be sure to like, share, and subscribe!

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