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.

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.

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.

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

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

Master Control has revolutionized the amount a single document controller can process. Prior to implementation there was a massive backlog of ECNs, now it rare to see an ECN take more than a day or two. I'm no longer going from desk to desk searching for documents.

Master Control automates a lot of our processes that were manual and paper based. Routing ECN/DCN have been a breeze within the software compared to how we manually did it in the past. The automation has allowed our company to process more changes at a faster rate which has made our customers very happy.

The only set back is not being able to fully customize everything to my liking. It's rather small and has not caused any significant issues, it's more of a personal preference.

MasterControl solves a lot of problems for us but it’s difficult to sell to our employees

QMS required training verification and retention

The difficulty in transitioning to new upgrades.

We have been using the Audit, Process, Documents and Training modules and find the interconnection between the modules to be the most useful functionality that we did not see with our other systems. MasterControl is easy to use and in most cases is intuitive in terms of the workflows and visibility to end users. The MasterControl Support team have been one of the best I've worked with and they will work quickly and effectively to ensure any issues are resolved and applicable feedback given.

Analytics / Reporting has been one of our main pain points and although there are many reports across the system and modules which show individual elements etc, there are not many reports which contain a full data set of information needed especially in terms of Training or Process reports. We also have some wishes for future enhancements to the software and this is where the MasterControl User Voice forum comes in most handy where users can submit ideas for enhancements as well as vote on other use voices.

Overall experience is good! Their customer service is definitely top-notch.

It's definitely a great quality compliance QMS that helps to control the quality. Everything has a record and cannot be simply removed or revised without a reason or explanation which makes it easy for auditing purposes.

Ease of use. I think this is the downfall of MasterControl Quality Excellence. The system itself is not intuitive and sleek. It's definitely a system designed based or how an engineer thinks but not so much of a normal everyday user will be using. User Experience (UX) is extremely important as more people are using digital applications and platforms.

Excellent, we are going into Mx in 2024

Ease to use and customize, being able to track progress and audit trail

It took a bit of time to create the base line for migrating all doc from previous platform

Overall not a bad experience. Wish the cost for classes was a bit less.

The supplier module, if set up correctly, allows the firm to set up all the various suppliers and link them to one another. The linking feature allows us to build a picture of the supply chain. Be sure to set up specific "Infocard" numbering schemes that match the various suppliers. For example, "Manufacturer-0001", "Vendor-0003", "Packager-0004". This way, when you link the infocards, you will immediately know the the entity is prior to opening the infocard. The ability to add custom fields is absolutely critical.

The contacts field needs a persons title field. Currently have to add the title next to the name of the individual which does not contain enough characters.

Overall, my experience with MasterControl has been very positive. From the product to the overwhelming customer support, if we don't have what we need it is probably because we don't understand or know about all the capabilities or haven't implemented a module yet.

We currently use docs and training and having all of that automated has been super helpful. Tracking metrics around training and docs has been much easier with data that can be downloaded at any time. Time spent chasing down training has been significantly reduced and has made the quality team more effective overall.

With the modules we currently use, I wish classes worked a little better. They are a bit difficult to set up and don't seem to integrate well with employee calendars, so extra invites are sent outside of MasterControl.

My overall experience has been great and the support team always has a live person to speak to for any questions or problems you run across.

I've been working with Master Control for over 20 years as a end user. I've seen the product and services grow over the past 2 decades. It is a robust software that allows me to centrally control all Quality Management System activities. When faced with a regulatory body audit, we are able to quickly retrieve documentation and satisfy the requests. I have been complimented on how easy the system is adaptable to our companies needs as we grow.

The only con would be Master Control has recently been modulating costs, so my advice is to be sure you are asking for explanation of what is and what is not covered when requesting a service.

I am the sysadmin and have learned a lot about the system. I think it is a powerful tool once you know how to use it.

It routes our documents along a workflow and it allows us to manage training in one platform

If a user hasn’t had a lot of experience with the system, they easily get lost.

Integration into other hubs in MasterControl

Some of the confirmations can have better data sharing and reporting.

By implementing MasterControl we have saved a ton of time with automated document revision control. MasterControl has made preparing for client audits much easier as our training data and documents are easily retrievable. It has certainly helped us be more efficient and compliant.

MasterControl quality excellence is easy to configure and maintain and does not require advanced IT knowledge. We especially like the OOS/OOT and document control/training capabilities. We love that the OOS/OOT process meets the FDA guidance exactly.

I would like to see a little more configuration options for the deviation and OOS/OOT process forms.

MasterControl provided us everything we need for employee training. Use of paper records is not only impossible to control with a growing facility, it is a regulatory risk. The software is easy to use and definitely worth it. I can't speak to the report management side of it but I imagine it gets the job done as well based on what I have seen for training.

Plenty of features available, including CCM, CAPA, NCR and more. We mainly use it for management of employee training. Previously, we used a paper based training system. MasterControl is easy to use from a management side and the user end. Our employees got it right away and it worked like a charm at our facility. When new trainings are ready, they immediately get assigned.

Navigation can be a bit difficult. There are some features we would like removed just for ease of use for our employees, especially new employees. These are very minor criticisms and ultimately it does exactly what we want it to do.

Really like the tool

Easy to use, configurable and scalable. Without needing to do too much customization!

Some features are limiting and she be configurable by admins (I.e. changing user passwords)

Scalability for a global organization with frequent acquisitions

License per module per user but have since switched to Qx Complete

There are so many different options you can choose to utilize to whatever best fits your company's needs. It's also great, because the different products can "communicate" with one another to pull information from one area to another. It saves our company so much time. Not to mention every time we have implemented a new product, it has been such a great experience. I know sometimes it can be stressful, but MC does such a great job at making the process as easy as possible. I truly can't say enough great things about the software of the company.

This isn't necessarily a software issue, we are hopefully upgrading to the cloud and we will have the new reporting system that we don't have now.

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.

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.

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.

At AcelRx we went from a paper based system to MasterControl and there is no comparison! Definitely made things so much better to keep control of documents.

Being able to have all our documents in one place is great. Launching DCO packets is so easy. Being able to log into MasterControl from anywhere makes collaboration easy for anyone to do especially since we have been working from home. Also having control of your documents and signature manifests from DCOs help to streamline audits. I also have to say that MasterControl has been the easiest system to help keep all users training up to date and on time.

with all the updates and upgrades the cons I had have been improved

Overall, MasterControl Quality Excellence has been a game-changer for our company as we grow and has helped us stay at the forefront or compliance. It has removed a lot of manual work and given us confidence in regulatory inspections.

MasterControl Quality Excellence (Qx) gives us the flexibility as a global organization to configure what we need, as we need it, without needing to edit code or re-validate the system. It allows us to manage compliance and track documents (with revision and access control), training, and quality events. In addition the system is hosted in the cloud, so we do not need to maintain our own infrastructure or IT team solely for the software. By being in the cloud, we receive frequent quarterly upgrades with new features, monthly defect patches, and global 24/7 availability. We also utilize the VxT validation tool, which cuts our quarterly upgrade validation time down to hours, and the customer support team is top-notch.

There are some quirks to the system that take some learning, but MasterControl has developed an excellent self-study library of courses to help. In addition, the older quality events module presented some configuration limitations that required us to adapt our processes to match MasterControl rather than the other way around. Fortunately, MasterControl's replacement of this module, Advanced Quality Event Management, just launched in 2024 and is alleviating this pain point.

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.

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.

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.

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