GetApp offers objective, independent research and verified user reviews. We may earn a referral fee when you visit a vendor through our links.
Our commitment
Independent research methodology
Our researchers use a mix of verified reviews, independent research, and objective methodologies to bring you selection and ranking information you can trust. While we may earn a referral fee when you visit a provider through our links or speak to an advisor, this has no influence on our research or methodology.
How GetApp verifies reviews
GetApp carefully verified over 2 million reviews to bring you authentic software experiences from real users. Our human moderators verify that reviewers are real people and that reviews are authentic. They use leading tech to analyze text quality and to detect plagiarism and generative AI.
How GetApp ensures transparency
GetApp lists all providers across its website—not just those that pay us—so that users can make informed purchase decisions. GetApp is free for users. Software providers pay us for sponsored profiles to receive web traffic and sales opportunities. Sponsored profiles include a link-out icon that takes users to the provider’s website.
MasterControl Quality Excellence
#1 Quality Management System for Life Sciences
Functionality
4.2
/5
422
Total features
92
13 categories
MasterControl Quality Excellence features
Common features of Quality Management software
Price starts from
25000
Per year
Other
Functionality
4.2
/5
422
Price starts from
25000
Per year
Total Features
92
Unique features
Operational Risk Management
Quality Assurance
Supplier Management
Product Data Management
Functionality
4.5
/5
630
Price starts from
100
Per month
Total Features
172
Features in Common
51
Unique features
Event Logs
Contract/License Management
Role-Based Permissions
Content Management
Functionality
4.8
/5
232
Price starts from
No pricing info
Babs C.
Pharmaceuticals, 5,001-10,000 employees
Used daily for 2+ years
Review source
Share this review:
MasterControl offers a robust InfoCard system that spans across various modules, enhancing the overall user experience. Document InfoCards effectively consolidate document files and associated metadata, providing a comprehensive overview, including document number, type, subtype, and custom fields
Unfortunately, my experience with jReports leaves much to be desired, particularly in its ability to handle large volumes of data. As someone who regularly deals with datasets comprising millions of lines, I found JReports to be quite inadequate in meeting the demands of such extensive data processing.
Katelind S.
Biotechnology, 501-1,000 employees
Used daily for 2+ years
Review source
Share this review:
- Easy to configure and modify when necessary - Very responsive customer service
- Process module is not very customizable (When customized, lose MC support if "breaks" during update) - Jump start package created a mess for our documents module
Carina W.
Medical Devices, 11-50 employees
Used daily for 6-12 months
Review source
Share this review:
The ability to keep all documents in one location with visibility being managed by rights in the system reduces the concerns in our previous paper-based system. Also the approval process being electronic reduces delays from those out of town who can now sign wherever they are.
The configuration abilities that allow you to make adjustments that apply most directly to your company.
The implementation of the software wasn't as clear and smooth as we needed.
Samantha B.
Biotechnology, 201-500 employees
Used daily for less than 6 months
Review source
Share this review:
I have loved how user friendly the platform is and how it allows us to more quickly close gaps as we strive towards ISO 13485 and FDA compliance next year. It allows for tons of efficiencies like 300% increase in records pushed through and allowing users to real time report quality issues.
The tracking/trending capabilities across the global business so we can escalate issues as needed and continuously optimize our products and processes. The ease of integration between modules allows for real time reporting and efficiencies for users. We released 300% more documents with this platform than our paper based system.
Some user features that are missing like doc number in my tasks and that CAPA due dates set based on risk scores.
Jim A.
Pharmaceuticals, 201-500 employees
Used daily for 2+ years
Review source
Share this review:
Overall experience has been very good. Overall it has allowed us to have a much better grasp on our quality management from the previous paper method.
The ability for tracking is great. We are able to link different types of forms together as needed.
Currently, the configuration and building of quality workflows is difficult to change. That is being changed soon with the release of AQEM though!
Charles F.
Medical Devices, 501-1,000 employees
Used daily for 2+ years
Review source
Share this review:
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.
Matthew M.
Hospital & Health Care, 51-200 employees
Used daily for 2+ years
Review source
Share this review:
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.
Donna D.
Hospital & Health Care, 11-50 employees
Used daily for 2+ years
Review source
Share this review:
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.
Peter T.
Biotechnology, 501-1,000 employees
Used daily for 2+ years
Review source
Share this review:
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.
Clayton S.
Medical Devices, 10,001+ employees
Used daily for 1-2 years
Review source
Share this review:
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.
Erik R.
Biotechnology, 1,001-5,000 employees
Used daily for 1-2 years
Review source
Share this review:
Validation on board, easy API Integration, QMS, and MES combined
EMEA backend support would be great, US support can sometimes take a while due to time difference
Betzaida S.
Biotechnology, 501-1,000 employees
Used daily for 2+ years
Review source
Share this review:
I always use master control every day in my scope of work. I am the trainer for the facilities and users. Found it very simple to work.
Easy to use and users are able to find what they’re looking for In real time
Publishing and search Still needs to be improved we have a lot of problems with publishing documents
Verified reviewer
Pharmaceuticals, 1,001-5,000 employees
Used daily for 2+ years
Review source
Share this review:
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.
Jeremy R.
Medical Devices, 501-1,000 employees
Used daily for 2+ years
Review source
Share this review:
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...
Lutz S.
Logistics and Supply Chain, 10,001+ employees
Used daily for 2+ years
Review source
Share this review:
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
Deanna V.
Medical Devices, 11-50 employees
Used daily for 1-2 years
Review source
Share this review:
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.
Anita K.
Pharmaceuticals, 1,001-5,000 employees
Used daily for 2+ years
Review source
Share this review:
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.
The seamless integration between the Documents and Training modules, and the willingness of MasterControl to listen to the users and continue improving the product.
Performing administrative corrections (e.g. fixing typos) on approved documents can be a little challenging.
Sara F.
Pharmaceuticals, 501-1,000 employees
Used daily for 2+ years
Review source
Share this review:
I have been a MasterControl admin for over 8 years. From the start, it was apparent that MasterControl is super customer focused and wants their customer to succeed in implementation and beyond. Their support is much better than what I've experienced with other software vendors and they value feedback and suggestions from the customers.
I love that all of MasterControl's modules are connected. Document management, training management, and Quality Event Management all talk to one another and help to streamline our processes. It's also very easy for basic users to learn.
My biggest complaint has been the lack of flexibility in Quality Event workflows. This is being solved by the new Advanced QEM product, which I'm super excited about.
Mark C.
Medical Devices, 51-200 employees
Used daily for 2+ years
Review source
Share this review:
Overall, MasterControl has been an excellent system to implement, decreasing the processing time of documents and allowing changes that need to be made quickly happen.
Quality Excellence is an extremely robust and customizable system that allows the users to create custom workflows for their document control processes. These workflows can be generalized for maximum usage across documents or specialized for an almost hands-off experience in the system.
The nuance of using the system can have a fairly steep learning curve. Currently, we are still finding little quirks in the system that can't be called generally good or bad. Just the fact that we are still learning different facets of the system tells how much there is to learn when using the system.
Donna J.
Pharmaceuticals, 501-1,000 employees
Used daily for 2+ years
Review source
Share this review:
We have been using MasterControl for document control for 23 years. We added the Process module over 15 years ago, and created many custom processes for quality management systems. MasterControl assisted us with the development of the 1st system, and provided continued support throughout the years as we added more and more. We added the field based solutions to ensure industry best practices and to streamline validation process. When we experienced compliance issues with our previous learning management system, we knew the answer was to add the MasterControl Training system.
MasterControl from Day 1 has let us know that we were part of the team! We have always been supported and knew we could depend on them on this journey for continuous improvement and greater compliance.
As a long-time user, we have had open honest conversations over the years MasterControl continues to improve their products, and I know they listen to their clients.
Richard R.
Medical Devices, 201-500 employees
Used daily for 1-2 years
Review source
Share this review:
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.
Tyler P.
Pharmaceuticals, 201-500 employees
Used daily for 1-2 years
Review source
Share this review:
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.
Katja A.
Nanotechnology, 1,001-5,000 employees
Used daily for 2+ years
Review source
Share this review:
MasterControl has a great amount of functionality to offer already and continues to develop its products, with ambitious and exciting roadmaps.
Moving our document change review and deviation processes from paper based into MasterControl has been an absolute game changer - the risk of losing records has reduced dramatically. We now have much greater visibility at which step in a process a document change is and who is involved in deviations.
Some of the user functionality can be not entirely intuitive, making it slightly more difficult to navigate for users who use the system only occasionally.
Elias C.
Medical Devices, 201-500 employees
Used daily for 1-2 years
Review source
Share this review:
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
Brenda J.
Medical Devices, 51-200 employees
Used daily for 2+ years
Review source
Share this review:
I have been working with MasterControl since 2/2011, v9.3. I cannot say enough about the support I have received over the years - you have an excellent team and I am grateful to them for all of their help. The support team goes above and beyond. I have found that more than 90% of this application to be user friendly and easy to navigate. And as I mentioned earlier, MasterControl continues to evolve and it just keeps getting better.
MasterControl is always evolving. I am so excited to learn that Power Bi will be embedded as Insights into MasterControl. The combination of these two products will make your users reporting experience so manageable. I love that our user voices are heard, even for the small things like adding the copy feature to user profiles.
We are on 2018.3, so not on the cloud yet. I am working to better manage our upgrades. I was disappointed when the dashboard feature was taken away. And jReports is totally not user friendly. I use it but the rest of my users just turn up their nose and ask me to create reports for them. Because of this struggle I have been creating reports in Power BI.