MasterControl Quality Excellence

MasterControl Quality Management system

Comentarios: 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.

Puntos a favor:

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.

Puntos en contra:

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.

7 successful years with MasterControl

Comentarios: 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!

Puntos a favor:

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

Puntos en contra:

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

Comentarios: Frustrating more than anything, primarily relating the cons listed. I inherited the system in a state that would have worked well on a small scale during initial adoption, but was completely unmanageable at scale. After years of cleanup, it's working better for us, but the system still leaves much to be desired, and after 5+ years of using it 5 days/week, I can tell you not a day has gone by that we don't experience a bug. Fortunately, they're rarely critical. As stated in the cons, it gets a passable performance, though it could be easily improved if they took the time to do so.

Puntos a favor:

The best feature of MasterControl as a whole is the process module. Process module allows custom electronic form development and allows custom routing for those forms. While it can be improved, it's a great tool, and in my opinion, MasterControl and most customers are not realizing its potential, but we do. 80% of our records are generated in the process module.

Puntos en contra:

There are a number of factors that all seem to coalesce to create a system that can easily become unmanageable. Those are poor documentation related to best practices that isn't easy to find or well communicated by MasterControl, lackluster support, and an already confusing user platform with a generally poor user experience. There are number of small improvements that could be made that would greatly improve user experience, but MasterControl rarely seems to develop enhancements. I've used several versions over the years, and in most cases, the user experience got worse, not better. Providing clearer/more readily accessible documentation, better support and recommendations for admins during initial setup, and making some small quality of life changes would really go a long way. With that said, that software meets all baseline requirements in satisfactory way.

Keep Your Business in Control with MasterControl

Comentarios: We are able to keep all of our manufacturing and quality documents under document control. Training is easier to manage and track. We can keep track of our suppliers, necessary internal and external audits, change controls, complaints, investigations, CAPAs, OOS, calibrations, etc. We use MasterControl for as much as possible and have leveraged their tools to digitize many paper processes. During audits, the MasterControl system presents very nicely.

Puntos a favor:

The seamless integration between the Documents and Training modules, and the willingness of MasterControl to listen to the users and continue improving the product.

Puntos en contra:

Performing administrative corrections (e.g. fixing typos) on approved documents can be a little challenging.

Qx is beginning to revolutionize our QMS

Puntos a favor:

Document control, change control, and review workflows are among the biggest challenges facing our organization. MasterControl provides the means to apply industry best-practices, and excellent control and compliance, with intuitive, out-of-the box solutions. MasterControl Qx also integrates with MasterControl's Mx (Manufacturing Execution) system, a critical reason we chose it.

Puntos en contra:

Onboarding has been challenging. This is not a flaw in MasterControl, but rather a feature: Connections, workflows, training, responsibilities, review cycles ... all have to be specified in detail. We didn't necessarily have all the information arranged in such a way as to make its entry into MasterControl 'easy'. However, once put together, the MasterControl system is far superior to its antecedent.