MasterControl Quality Management system

MasterControl has allowed us to replace book shelves of policy binders, file cabinets of employee training and competency forms. Staff can all access the same document at the same time instead of waiting for the binder to be free. Regulatory requirements are easy to track within the system.

Pros

This system is flexible enough for a any regulated industry. It includes a document management module, employee training module, Quality module that included Deviations, CAPA, Change Control, non-Conformance; Quality, risk management, etc.

Cons

The suite of modules has not been certified as HIPAA compliant, except for the Documents module. Full HIPAA compliance is on their timeline for 3rd quarter 2020.

System Integration

We needed a validated system to replace our existing homegrown systems. The integration of the modules made this move a relatively painless one.

Pros

We went from several home grown or small scale products and rolled them all into one with MasterControl. It significantly lowered our risk, makes our processes more efficient, and streamlined ongoing system maintenance and support. Many systems are good about recording information (all the inputs) but don't put much effort into the outputs. MasterControl makes it easy to pull out the information you are looking for and schedule specific reports for delivery when needed.

Cons

Being new to the medical device world, the sign offs and approvals seems cumbersome, but I would expect those from any system in this arena. That was a little to get used to, but it is setting us up for success when it comes audit time.

Mission Critical Quality Excellence

It has really helped us solve many issues with quality control and compliance. I would recommend this product to anyone who wants to move to the top tier of quality for their product.

Pros

This software is a complete solution with more modules you can add being built all the time. It is cloud based and does more than any in house solution could be built to do for the same price. The support team is very responsive in accepting our suggestions for improvements.

Cons

Even though there is a lot of support, it can be time consuming and very labor intensive to integrate the many pieces needed to implement the entire solution. It is a bargain but still very pricey for a small company and this will eventually limit its market.

Most unintuitive software I've ever been forced to use

There are company-wide jokes about "Master Control Hell". At least it lets us bond in our commiseration.

Pros

Umm... that's really hard to say. Pretty colors, I guess.

Cons

Navigation is difficult. "Help" is convoluted - no easy way to find answers. For example, I wanted to know where my task disappeared to after I clicked Launch. Could not find an answer. App stalls very often with back button. I could go on, but I'm tired. I've been trying to navigate Master Control for the last 3 hours.

Implementation of Doc and Training

We had a paper training process and used PDM for document control, which was not ideal because the user had access to prior control document revisions. Once we were able to inventory our procedures and forms, we were able to implement a solution that is long term sustainable We know we hit the jackpot, when the [SENSITIVE CONTENT HIDDEN] of the company said that was able to do training very easily because the document was attached to the training. He didn't need to attend training on how to use the software to figure out how do complete his procedure assignment training.

Pros

1) For the user, it was very easy for the user to complete training. Steps are very intuitive 2) Implemented a document control solution that prohibited certain users from seeing archived versions of the documents. 3) each to find document by searching by datacard elements

Cons

didn't set up data card structure as best that we could.