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.

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.

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.

We have been using MasterControl since 2016 and since then we have NEVER received an Audit finding (neither by our ~global customers, nor any regulatory body like DQS, district government or even FDA).I feel secure and relaxed, knowing our quality documents are in a secure, validated system that I can access from anywhere, and that they sit in a system even our customers and the regulators themselves are utilizing!As a Pharma/MedTech logistics company, an electronic QMS system is a necessity and we are looking forward to utilizing more innovations with our imminent move to the MasterControl Cloud, especially because of the very promising AQEM solution!

Document Collaborations, Deviation/CAPA forms, training structure (Course/Exam/JobCodes/Trainee) is excellent

Too many bugs in necessary utilities like Action Items and Extension Requests, Management of Change module not up to our quality standards, Jreports are very user unfriendly

MasterControl works as a document management and training module. It is not as robust as I would like but it is relatively easy to work with. The customer service is above average.

The strength of MasterControl is that it is easy to configure. For documents and training someone new to MasterControl can take the free online training and be at a module admin level in 2-3 months. For the most part changes do not need to be validated because the configurations are so limited that the OQ/PQ can justify functions.

The weakness in MasterControl is that the configurations are so limited. There are often times when you expect the system to be able to do something only to find out that it is not fully capable of what you expected. And example would be setting up prerequisite courses. This would be a great feature for creating an entire curriculum. But a course can only have 1 prerequisite, when you might have expected to be able to assign multiple prerequisites. Since this feature/configuration is so simple the admins end up having to play a greater role in assigning training, because the system can't be configured in a complex fashion. While about 80% of the configuration make sense, the other 20% does not. Some features and configurations are just not intuitive.

The customer service and technical service has been excellent!! I've never worked with a friendlier or more helpful partner. The overall experience with MasterControl has been superb!!

I like the seamless integration between the Documents and Training modules. We have totally eliminated paper training records, eliminated manual record tracking and filing, and we have ready access to all required records during audits and inspections. As FDA registered facilities we needed FDA part 11 compliance and audit trails. MasterControl has given us all these capabilities in an intuitive and easy to use paltform for all users.

We had to do our homework when initially configuring the software to understand how to make the right decisions and allow the system to scale with our own evolution and growth. We knew where we wanted to end up, but didn't understand all the new terminology, or exactly how the system worked. We hired a third-party consultant recommended by another MasterControl user and leveraged their expertise to bridge the knowledge gap between us and MasterControl. The initial configuration took longer than we originally planned, but we ended up with a configuration that works very well for us.