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MasterControl Quality Excellence Reviews

About MasterControl Quality Excellence

MasterControl, the No1 QMS in life sciences, automates compliance by connecting audits, training, document control, and quality events.

Learn more about MasterControl Quality Excellence

Pros:

Master Control provides great costumer services.

Cons:

Requires very skilled and trained employees to execute the daily business processes. Lack of design / GUI customization.

MasterControl Quality Excellence ratings

Average score

Ease of Use
4.1
Customer Service
4.5
Features
4.2
Value for Money
4.2

Likelihood to recommend

8.2/10

MasterControl Quality Excellence has an overall rating of 4.5 out 5 stars based on 422 user reviews on Capterra.

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Filter reviews (422)

Justin
Justin
Sr. Quality Assurance Associate in US
Verified LinkedIn User
Biotechnology, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

Feature Rich and Compliant eQMS

5.0 2 years ago

Comments: Like many MC users, we started with doc control and training. This allows us to technologically link the two processes together. New revision to an SOP? Training automatedly is sent to users. Want to ensure training is complete before release? MC can delay the release until a specified amount of training is completed. MC also provides QEM solutions which can further support all other aspects of the QMS.

Pros:

MC provides a solid framework for any QMS. You are able to adapt any process into MC with minimal modification. MC is also a fully integrated platform and nothing in the software works in isolation. Training, document control, QEM; all of it works together.

Cons:

MasterControl isn't intuitive. There is a lot of training that needs to go into its use, especially if the person is doing more than just accessing SOP and performing training. However, MC does provide A LOT of training resources which takes some of the burden off of admins.

Betzaida
Betzaida
IT QmS manager in Ireland
Verified LinkedIn User
Biotechnology, 501–1,000 Employees
Used the Software for: 2+ years
Reviewer Source

Alternatives Considered:

Veranova -QE

5.0 4 months ago

Comments: 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.

Pros:

Easy to use and users are able to find what they’re looking for In real time

Cons:

Publishing and search Still needs to be improved we have a lot of problems with publishing documents

Jeremy
Sr. Manager, Software Quality Assurance in US
Medical Devices, 501–1,000 Employees
Used the Software for: 2+ years
Reviewer Source

MasterControl

3.0 last year

Comments: 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.

Pros:

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.

Cons:

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.

Lutz
International QA System Administrator in Germany
Logistics & Supply Chain, 10,000+ Employees
Used the Software for: 2+ years
Reviewer Source

Alternatives Considered:

7 successful years with MasterControl

4.0 last year

Comments: 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!

Pros:

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

Cons:

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
Q&R Manager in US
Medical Devices, 11–50 Employees
Used the Software for: 1+ year
Reviewer Source

Alternatives Considered:

Implementation of Doc and Training

5.0 4 years ago

Comments: 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.

Anita
QA Process Manager in US
Pharmaceuticals, 1,001–5,000 Employees
Used the Software for: 2+ years
Reviewer Source

Alternatives Considered:

Keep Your Business in Control with MasterControl

5.0 last year

Comments: 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.

Pros:

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

Cons:

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

Sara
Sara
Quality Systems Manager in US
Verified LinkedIn User
Pharmaceuticals, 501–1,000 Employees
Used the Software for: 2+ years
Reviewer Source

Alternatives Considered:

Connected and Compliant eQMS

4.0 11 months ago

Comments: 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.

Pros:

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.

Cons:

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
Quality Engineer in US
Medical Devices, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

Alternatives Considered:

MasterControl Quality Excellence: A Quality Product

5.0 7 months ago

Comments: 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.

Pros:

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.

Cons:

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.

Richard
Associate Quality Engineer/Doc Controller in US
Medical Devices, 201–500 Employees
Used the Software for: 1+ year
Reviewer Source

Alternatives Considered:

One of the best value for your money

5.0 last year

Comments: 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.

Pros:

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.

Cons:

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.

Brandee
QA Technology Specialist II in US
Biotechnology, 501–1,000 Employees
Used the Software for: 2+ years
Reviewer Source

Great Quality tool/resource

4.0 7 months ago

Pros:

When comparing MasterControl Quality to our previous system, MasterControl is far more user friendly when it comes to searching for documents and overall organization of everything. The design is also more modern and nice to look at.

Cons:

There are some areas that are a little bit more difficult to navigate or that aren't as intuitive to users that are not as familiar with technology.

Verified Reviewer
Verified LinkedIn User
Pharmaceuticals, 1,001–5,000 Employees
Used the Software for: 2+ years
Reviewer Source

Flexible & Scalable Modern Quality Management System

5.0 6 months ago

Comments: 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.

Pros:

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.

Cons:

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.

Jonathan
L&D Manager in US
Hospital & Health Care, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

Alternatives Considered:

MasterControl User Feedback

4.0 12 months ago

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

Pros:

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.

Cons:

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.

Brenda
IT Analyst in US
Medical Devices, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

IT JUST KEEPS GETTING BETTER!

5.0 4 years ago

Comments: 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.

Pros:

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.

Cons:

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.

Brittany
Quality Systems Administrator in US
Pharmaceuticals, 201–500 Employees
Used the Software for: 2+ years
Reviewer Source

Initial Site to Multiple Sites

5.0 5 years ago

Comments: I've been a MasterControl System Administrator for two different types of companies now. Both companies started using MasterControl at one site and have/are spreading the usage of this software to their international locations. The process to deploy to other locations is very controlled and Administration has plenty of options in regards to how much data can be made available between the two.
Overall, great solution to the answer many of the needs of a company in today's regulated industries.

Pros:

MasterControl bridges many of the critical functions of a regulated industry. The ability to have documents/training/audit/event forms/projects and more interacting directly is a huge advantage. All of these processes are required anyway, why waste resources on individual manual systems or separated software systems? MasterControl brings all of the benefits of a non-manual process with additional bonuses due to the inter-connectivity.

Cons:

The pricing is quite steep - especially in regards to licensing it's always a significant business decision to invest in more. The upgrade/enhancement process is actually designed well with the exception of retroactive updates. Many new/requested features are implemented in newer versions but upgrading is also a significant business decision.

Kornkaew
Quality system and Quality assurance in Thailand
Food Production, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

Good software for Quality system

4.0 last year

Comments: Almost feature compliance QMS then we recommend implement for company who certified ISO 9001 and others.

Pros:

Deviation and CAPA , these are compliance with ISO 9001 to manage Non-conformity. There are cover since investigation the root cause, risk assessment evaluation after the action to prevent recurrence problem. Which compliance the ISO 9001 requirement. When auditor audit that is easy to understand.

Cons:

For me the feature are good but the security of access is not easy. I'm not sure that it's from IT set up or from Master control Excellent team.When my colleague are not access 1-2 month, when they access for Document review or investigation deviation, we always found cannot access. And require deactivate PW. It's not familiar to set up PW and remember when change.

Aubrey
Manager, Quality Systems in US
Biotechnology, 51–200 Employees
Used the Software for: 1+ year
Reviewer Source

Increased compliance and efficiency

4.0 2 years ago

Comments: The overall experience has been great. The pros much outweigh the cons. We are looking forward to MasterControl expanding features even more and learning how to better use our existing ones.

Pros:

Document control has been the most impactful. We are not losing documents, manually tracking them down, and can now approve from anywhere. Our compliance has dramatically improved and also our efficiency.

Cons:

There are still some gaps in features to make a quality system entirely paperless. We are not able to transition logs over because they don't entirely fit anywhere. FBS forms do not have the functionality we are looking for. We use Mx a lot as fillible forms for things such as donor screening and QC testing where more calculations and documentation are required.Configuration can be difficult depending on who the consultant is. You get a broad range and a different experience with each different person, some more pleasant experiences than others.

Sarah
Quality Engineer in US
Pharmaceuticals, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

Quirky, But Gets the Job Done

4.0 8 months ago

Comments: Overall it's fine. Always room for improvement! But it works.

Pros:

I like how customers are able to configure many things on their own, as opposed to submitting a ticket each time something needs to be configured a different way.

Cons:

There are some round-about ways of doing things. Guest user set-up, for example, is not done like regular users. If you go to the list of Guests, there's no "+" to add a new Guest user. Instead, you have to find a collaboration step in your tasks somewhere, then modify step, then click "Add Guest" (which also doesn't make sense because you're not adding them to this step), then fill out the guest user's information to create the Guest's credentials.

Gen
Training Specialist in US
Pharmaceuticals, 201–500 Employees
Used the Software for: 2+ years
Reviewer Source

MasterControl Multisystem User

5.0 5 years ago

Pros:

The customer service for any and all software issues simply cannot be beat. Employees are generally timely and knowledgeable in their responses. Although in the past, the fixes that the company has had to issues were sometimes just work-arounds, recently any representative I've worked with has been extremely thorough in resolving issues. System has undergone several huge improvements where I am much happier using the system as an administrator. System has decent logic to resolve issues for end users.

Cons:

When the system gets upgraded, it always brings out a ton of unexpected issues. We know that we will have to dedicate a couple of days just to watching for problems. Casual end users have a hard time understanding the system often, and there isn't a ton of training content available from the company for basic users to help ease the transition.

William
Manufacturing quality engineer in US
Medical Devices, 1,001–5,000 Employees
Used the Software for: 2+ years
Reviewer Source

Alternatives Considered:

MasterControl Qx is a great tool for compliance in documents management

5.0 11 months ago

Pros:

Integration into other hubs in MasterControl

Cons:

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

Donna
Document Control Specialist in US
Biotechnology, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

You get what you put into it

3.0 2 years ago

Comments: System is good but can require a lot of workarounds. Not as intuitive or user friendly ad it could be.

Pros:

Great system for training compliance. Allows us to effectively track training compliance

Cons:

Some difficulty with assigning classroom training. Cannot select more than one trainer at a time

Michael
Sr. Director, Regulatory Affairs and Quality Systems in US
Medical Devices, 201–500 Employees
Used the Software for: 2+ years
Reviewer Source

Alternatives Considered:

Excellent product

5.0 2 years ago

Pros:

I don’t have to think about my EDMS. The system features assure compliance and efficiency.

Cons:

Training features are frustrating in the sense that documents are inaccessible to users who have not completed a training task.

Hannah
Quality Systems Specialist in Ireland
Biotechnology, 501–1,000 Employees
Used the Software for: 1+ year
Reviewer Source

Alternatives Considered:

Better than bespoke but not excellent yet

3.0 4 months ago

Comments: The user interface is not user friendly but the product works as intended

Pros:

It is easier to maintain than a bespoke QMS

Cons:

The lack of configurability pre AQEM which we haven’t implemented yet

Erik
Transfer and Product Support Engineer in Ireland
Biotechnology, 1,001–5,000 Employees
Used the Software for: 1+ year
Reviewer Source

Great QMS and MES combination

5.0 4 months ago

Pros:

Validation on board, easy API Integration, QMS, and MES combined

Cons:

EMEA backend support would be great, US support can sometimes take a while due to time difference

Eli
Solutions Architect in US
Medical Devices, 1,001–5,000 Employees
Used the Software for: 2+ years
Reviewer Source

Qms

4.0 2 years ago

Comments: Very good customer service for any issues.

Pros:

One eco system, training and now the ability to do insights.

Cons:

It's starting to look dated. Searches and results are limited.

Brenna
Quality Engineer in US
Medical Devices, 51–200 Employees
Used the Software for: 2+ years
Reviewer Source

Alternatives Considered:

I heart MC

4.0 2 years ago

Pros:

I love that MasterControl works toward being a one stop shop for everything quality.

Cons:

Troubleshooting can be difficult with less tenured front line service staff.