MasterControl Quality Management System (QMS) Software


MasterControl QMS is an integrated quality management system that can be installed on-premise or accessed through the web. It is suited for businesses of any size and a multitude of industries including agriculture, lumber, industrial machinery, plastics, and pharmaceuticals.

MasterControl enables over 1,000 customers across 30 countries to get their products to market at reduced cost with efficiency while eliminating the need for paper-based quality processes and adhering to FDA and ISO quality standards.

MasterControl QMS helps you automate task assignment, scheduling, follow-up, tracking, escalation, review, and approval of all document-based processes.  The core application in the MasterControl suite integrates all quality processes including change control, customer complaints, corrective/preventive action (CAPA), and audits.

MasterControl also offers a supplier management tool that allows you to meet the needs and maintain all supplier status and quality information in a central location and includes an approved vendor list that can be made available organization-wide and reviewed in real time.



56 Reviews of MasterControl Quality Management System (QMS)

Overall rating

4.68 / 5 stars

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Showing 1 - 20 of 56 reviews

August 2017

Lillian from Maxtec LLC

Company Size: 51-200 employees

Review Source: Capterra


Ease-of-use

3 of 5

Value for money

5 of 5

Customer support

5 of 5

Functionality

5 of 5

August 2017

The 'Adobe' of eQMS: Extremely powerful functionality with a learning curve well worth the effort.

Increased productivity, compliance, visibility, and capability.

Pros

1) One-stop shopping for Document Control, Training, CAPA, Complaints, Change Control, Supplier Management, Bill of Materials, etc. All processes are electronically linked, adding both ease and traceability to my interrelated QMS processes (I can launch a CAPA from my Complaint form!) (I can launch an Engineering Change Order from my CAPA form!)
2) Configuration can be as simple or as complex as you make it. The more complex configurations are more work up front, but bullet-proof the processes for the end-user so the processes pretty much drive themselves.
3) Makes audits so much easier to facilitate and eliminates the low-hanging fruit that is so easy for auditors to find; no missed signatures, no GDP issues, no data integrity concerns, etc.
4) Technical Support has my questions answered almost immediately whether I call directly or issue a web-ticket. More complex questions are escalated directly to the engineers who are also incredibly responsive.
5) My product feedback is solicited and responded to. MasterControl isn't an unreachable entity; they care what the end user has to say and are constantly soliciting feedback.
6) Form Builder! The eForm Builder and Process module are addictive. I can build an HTML for for any time-wasting paper-based process that I have. They go through the electronic workflow and can link to any other MasterControl module, form, etc.

Cons

1) The cost is understandably high (it does the work of 2-3 people in my 80 person company) but it can be difficult to get management past the sticker shock when they're thinking of traditional plug-and-play software (and asking management to spend money on Quality is already tough).
2) As mentioned in the opening line, the learning curve is a bit steep. This is not a drag-and-drop, push-to-install software. You need a trained System Administrator to navigate not just how to do the basics, but how to really harness the full, powerful potential of the software. Buying the software, attending one intro courses and then calling it good is like buying an espresso machine only for the hot water. You need to learn what all the buttons do to make it a real, worth-while investment. Luckily MasterControl has an Online University with really helpful tutorials, plus a great online help menu. And Tech Support for everything else.

August 2017

Thomas from Wright Medical Group, N.V.

Review Source: Capterra


Ease-of-use

5 of 5

Value for money

5 of 5

Customer support

5 of 5

Functionality

5 of 5

August 2017

Amazingly Robust, Compliant and Easy to Use

Pros

I've been the Administrator of this software at our company for over 10 years. We currently utilize the Documents, Process and Training modules along with a few HTML based eForms such as Change Control, Manufacturing logs, etc. The collaborative tool for reviewing and redlining documents has provided the necessary exposure and transparency to our organization on document reviews. In addition, we've kick it up in our training module by purchasing and utilizing UL Eduneerings Compliance modules which is SCORM compliant. Works great and eliminates the use of going outside of MasterControl to complete compliance training.

Over the years, MasterControl has made significant improvements to provide more automated functions that reduce human error. We've taken advantage of those tools. The proof really is in front of regulatory agencies such as FDA, Notified Body, TGA, etc where every time I was audited for he functions I managed (Document Control, Training, Change Management, Records Control and HR), I was able to demonstrate controls and compliance over the entire Document, Training and Change Management systems. We've received high remarks from these agencies on system.

Cons

Like any software, there are various issues, albeit out of the control of MasterControl at times. For instance, MasterControl may not behave the same in various versions of Internet Explorer. MasterControl is good to call out in their Hardware/Software Recommendations document what systems and software plays naughty and nice with their system (e.g. I.E, Java, Google Chrome, Adobe, Servers, etc).

What's in their control that is not so great is the reporting tool. However, that should be addressed later this year.

September 2017

Joanne from UC San Francisco Medical Center

Company Size: 5,001-10,000 employees

Review Source: Capterra


Ease-of-use

4 of 5

Value for money

5 of 5

Customer support

5 of 5

Functionality

5 of 5

September 2017

Flexibility for all specialties with great modules for your regulatory needs.

Removed all SOP binders in our department. Staff training records also eliminated and are all in soft copy and easy to find. MasterControl makes documentation management easy. Regulatory agencies that review our sites are impressed with the system and ease in finding what they have requested. Department supervisors were able to eliminate many lists reminding staff of document review dates, required reading and new information. Staff meeting minutes no longer left in a break room for staff to read and initial. MasterControl sends it out to appropriate staff and requests an electronic signature. The internal report writer is easy to use and presents real time data in seconds.

Pros

This application is installed at a university hospital with many diverse regulatory needs. From CLIA and CAP in Pathology and Clinical Laboratories to AABB and FACT in Bone Marrow Transplant programs. Documents, Training and Process modules are flexible enough to meet the diverse needs of each specialized department while allowing the departments to tailor the system to meet their workflow needs. All documents are available to the staff that need them in the most recent version wherever they need them. We utilized PC's, laptops, iPads and hyperlinks within departments Intranet sites. Completing all template fields allows for great automation and the elimination of lists of due dates, signature lists and manual training tracking.

Cons

For staff that do not author/edit documents routinely it can be hard to know where to begin in the application. We upgrade every 2 years and the design can significantly change enough to confuse people.

September 2017

Crystal from McKesson

Company Size: 1,001-5,000 employees

Review Source: Capterra


Ease-of-use

3 of 5

Value for money

5 of 5

Customer support

5 of 5

Functionality

4 of 5

September 2017

Possibilities are Endless!

Pros

There are so many opportunities to use this software to help manage aspects of your business or quality system that would be impossible in a paper based or manual process. While the modules are defined and designed around a specific function, you have the flexibility to create custom configurations and shape the product to fit your needs. The customer support from the entire MasterControl group is amazing!The level of service is very high from everyone you interface with, the sales team, the install team, the front-line support team, etc. We also use the TAM support service in addition to front-line support and we have greatly benefited from building a relationship with our TAM and troubleshooting system issues. Overall, this investment will help support rapid growth in your business and help facilitate the creation and management of a truly robust quality organization.

Cons

There is definitely a learning curve with this software for users, and with the size of our organization and the constant influx of new personnel the establishment of an ongoing support team is key to the success of the product. Some of the components are not the best out of the options available on the market, but bringing them all together in one package is what makes this product sustainable.

September 2017

Jill from Cypress Medical Products, LLC

Review Source: Capterra


Ease-of-use

4 of 5

Value for money

5 of 5

Customer support

4 of 5

Functionality

4 of 5

September 2017

MasterControl software meets the regulatory requirement for automated systems.

Pros

All modules revolve around the infocard which is used to establish documents, training, audits, suppliers etc. Once you understand how to configure the infocard for one module, it is very easy to configure add additional modules to support the quality system. We started with the documents module and have expanded to include training, complaint, audit, supplier, non-conformance and a few customer forms. We have done most of our own configuration with minimal assistance. We also like the info card set up because it makes it so easy to file all product related documents in one location. We recently set up an infocard for each specific item and we have been to link specific suppliers, inspection reports and other item qualification activities directly to the info card. This allows for easy access in the event of an audit from an outside agency.

Cons

Customization of the out-of-the-box software version is very challenging. Also, the audit module is not very user friendly. A "work add-in" is needed on versions 11.4 and prior in order to generate an audit checklist and subsequent report. Installing the word add-in is difficult when the software is maintained behind a firewall.

August 2017

Matthew from OrthoPediatrics

Review Source: Capterra


Ease-of-use

4 of 5

Value for money

5 of 5

Customer support

5 of 5

Functionality

5 of 5

August 2017

Our company is safer, stronger, and better because of implementing MasterControl

Pros

This software is extremely powerful and has many applications all throughout a corporation.

It has many opportunities for expansion through additional modules.

The Sales and Customer Service staff is amazing in every way, especially by being patient and courteous, but also extremely knowledgeable!

Our company brought in MC to fill a need in electronic document management control. But we did not realize how much we needed it for our processes and procedures specifically! It is so adaptive and configurable that it meets our needs in almost ever way.

Cons

It has a large price tag, but it is backed up by service, support, and exceptional functionality.

Our own version is not the latest and greatest, so it does not have all the bells and whistles. But what it does have suits our needs very well. However, there are some limitations on hardware and software requirements that do conflict with other parts of our infrastructure. We are having to make compromises in some areas. But as soon as we can upgrade to the latest version, many of our issues will be resolved and we will be able to add even more functionality and capabilities.

January 2018

Kim from Biotechnology

Review Source: Capterra


Ease-of-use

3 of 5

Value for money

4 of 5

Customer support

4 of 5

Functionality

4 of 5

January 2018

Solves many issues, but has a big learning curve

Pros

Many issues that happened in our paper system were solved like keeping track of revisions and having a centralized place for comments and collaboration. The automation also helps a lot with compliance and the v11.6 reporting features are great. The training module finally forced us to define which department should be trained on which documents and really improved our training system.
As someone who went to a MasterControl Summit, the people who work there are really down to earth and personable.

Cons

It requires a big learning curve and your users will make a lot of mistakes in the process. Switching to MC can require a complete overhaul of your numbering system, which makes the transition much harder. The UI has room for improvement, especially because they use the same symbol to mean different things in different contexts.
I also wish there was more control over user rights, like editing InfoCards and replacing the main files. We've run into issues with users not understanding that process and it has created audit findings.
The inconsistent knowledge of tech support. I'll ask one person a question and get one answer, then ask another person and get the opposite answer.
Finally, I find that the UserVoice feature is a joke.

October 2017

Anonymous

Verified Reviewer

Review Source: Capterra


Ease-of-use

4 of 5

Value for money

3 of 5

Customer support

3 of 5

Functionality

4 of 5

October 2017

My experience overall is positive. Yes, there is room for improvement but this company aims for it.

Pros

Everything an end user could ever want or need from a QMS comes together in such a way that our end users believe in magic. Its really up to the company (and sometimes department) to decide what level to use the software on. Its easy to get creative with this product and really optimize a already great web based software. Everything is right there, right at your fingertips - all the time!

Cons

Sadly, the set up is not magical and not everyone can wrap their head around the system. Finding competent admins could be an issue. Everything does effect everything else in this system and you need to ahave the forsight to see and understand that.

My largest complaint however is that the company could also be more forth coming with issues within their software. They have a lot of what they call bugs. I think these "bugs" are often not fully vetted until a customer points them out, then I imagine there is a lot of running around and work arounds.

That said, it is a great system that works incredibly well to keep you and your company complaint.

August 2017

Linda from Adventist- Florida Hospital

Review Source: Capterra


Ease-of-use

5 of 5

Value for money

5 of 5

Customer support

5 of 5

Functionality

5 of 5

August 2017

Our department (laboratory) has been with MasterControl since 2013 and basically everyone in the lab

Pros

Our department (laboratory) has been with MasterControl since 2013 and basically everyone in the lab is very comfortable with the product. It has reached a point that while during our recent upgrade one our modules was not functioning 100%, forcing our end users to go back to paper for part of the process. This caused alot of discord to say the least and it only lasted a few weeks. Also, now Mastercontrol is always on the top of our list as part of the solution to the majority of our issues. Word is getting out and alot of other departments in the hospital are asking us about the product. They especially love the fact that document control and training are tied together. This is always a struggle in healthcare (documenting training/competency and assuring that SOPs/policies are being read and understood).

Cons

There are some areas that are obviously not geared toward how modern clinical laboratories do document control, but as they get more and more clinical laboratory clients I suspect that will change.

February 2016

Roger from Moxtek, Inc.

Review Source: Capterra


Ease-of-use

4 of 5

Customer support

5 of 5

February 2016

MasterControl - the foundation of our Integrated Management System (IMS)

We use MasterControl for Document Control, Training, and Corrective Action. Implementation of these core processes will help you comply with international Management System standards. When you choose MasterControl as a partner, they will help you by: 1) Developing a Project Plan customized to your needs. A MasterControl project manager helps you define the activities and milestones that will support your "customer success" goals. Customer success will be measured after implementation. 2) Ensuring you are trained. System Administrators get training on the Modules purchased to help ensure success. Companies frequently send both a technical IT person supporting the project and a non-Technical Module Admin to this training at their headquarters. During SysAdmin Training, customers learn about the MasterControl software and how to be ready for their on-site configuration. 3) Setting up your system. MasterControl Professional Services consultant/s will come on-site to help the SysAdmin configure the system and import current documents. MasterControl Professional Services consultants will normally also perform initial User Training while on-site. 4) Providing Tech Support. There will surely be minor issues that come up that need a techie to review and fix. MasterControl has trained, experienced, and friendly Tech Support personnel. I feel MasterControl's strong support network is really a competitive advantage. I've worked with similar companies that do not provide the support you need and aren't as responsive or professional. Best of all, they track and follow-up on your issues. 5) Making system improvements. MasterControl listens to customers - this shows up in many ways. MasterControl provides customers with a user-friendly interface to propose enhancements and to network with other customers. I've personally had enhancement requests implemented into the system. MasterControl has consistently added new features, capabilities, and expanded functionality to new areas based on customer feedback. Overall, I have been completely satisfied with choosing to partner with MasterControl. Again, it doesn't mean that I always get perfect products and services, or always get my enhancements addressed immediately or in the way I would prefer. It does mean that MasterControl has helped our company with successful implementation of our Management System foundation that we continue to build on.

October 2018

Rachael from ERT

Company Size: 1,001-5,000 employees

Review Source: Capterra


Ease-of-use

5 of 5

Customer support

5 of 5

Functionality

4 of 5

October 2018

Easy to use and MasterCOntrol have an excellent support service

Our overall experience with MasterControl has been excellent, from the start of the project through to now. When we looked for a new QMS, MasterControl stood out from the other vendors we contacted. We have now streamlined our Complaints and CAPA process and have one central database instead of the multiple systems/databases that we had. We are now looking to implement Documents and Training... so the MasterControl adventure continues!

Pros

As a System Administrator of MasterControl, I really like how easy the system is to use and how our quality documents can be maintained in one central system instead of the multiple systems we had previously been using. The service offered by MasterControl has been excellent and we have worked with some amazing people during the configuration of the system. We also rate the Customer Support team as they are quick to respond to your issue and offer solutions quickly.

Cons

Currently the J-Reporting as we aren't finding it as simple to use as we expected. It's a very powerful tool to use but we've need a lot of support from MasterControl to develop our company-specific reports.

August 2017

Ryan from Cochlear Americas

Company Size: 501-1,000 employees

Review Source: Capterra


Ease-of-use

5 of 5

Value for money

4 of 5

Customer support

5 of 5

Functionality

4 of 5

August 2017

We have compared MC to other document controls tools and MC have always been our choice.

Pros

We have been a Master Control customer since 2007. The system has streamlined our document control process. The ability of the system to connect all the different modules makes it easier for us as a Medical Device regulated to comply to regulations.

Our users complement how user friendly the system is and how customizable it is in terms of searching for document based on metadata or by drag and drop.

The use of the form builder tool allowed us to moved several paper based process to electronic. The forms are easy to build and lets you customize it as needed.

Their tech support staff is friendly and very knowledgeable and if they don't know the answer to something they get back to you in a timely manner.

Cons

There is room for improvement in reporting. Master Control has already identified this gap and planned to include in future releases.

January 2017

Patrick from The Institute for Transfusion Medicine (ITxM)

Company Size: 1,001-5,000 employees

Review Source: Capterra


Ease-of-use

5 of 5

Value for money

5 of 5

Customer support

5 of 5

Functionality

5 of 5

January 2017

MasterControl Excels as an eQMS

ITxM purchased the MasterControl eQMS suite in 2004 and has been using the platform for Document Control, Training and Nonconformance Management. The software is very user friendly, and the Customer Support from Sales through Technical Account Management is exemplary. Upgrading the software has become easier and easier over the years, and we have never had any questions about the installation or validation of the system from any of our regulatory inspections; and we have lots of inspections, assessments and accreditations. The annual User Summit allows customers from all industries to come together and discuss best practices and share experiences. I would recommend MasterControl for any size company, both regulated and non-regulated. And if you don't have the internal resources to install the software, MasterControl can assist by hosting the software for you.

Pros

Easy to use and great customer support

Cons

Top dollar, but you get what you pay for.

February 2019

Kristin from Swanon Health Products

Company Size: 501-1,000 employees

Review Source: Capterra


Ease-of-use

5 of 5

Value for money

5 of 5

Customer support

5 of 5

Functionality

5 of 5

February 2019

A great company with an even better product.

Pros

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.

Cons

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.

February 2019

Yasmine from Cytokinetics

Company Size: 51-200 employees

Review Source: Capterra


Ease-of-use

5 of 5

Value for money

5 of 5

Customer support

5 of 5

Functionality

5 of 5

February 2019

Cusotmize Customize Customize!

MasterControl has enabled our business to automate processes and capture electronic training and document approvals saving time and money and empowering end users to take control over their documents and processes.

Pros

I have been using MasterControl since 2004 and love the customization options available to me and my end users. You can customize just about anything in the system and make it your own. As a system administrator, its my job to deliver a product to my end users that is easy to use and that meets all of their needs and MasterControl gives me that ability.

Cons

MasterControl works best in Internet Explorer and has hiccups in other browsers, which tends to cause some confusion with end users.

February 2016

Joanne from KaVoKerr Group/Dental Technologies

Review Source: Capterra


Ease-of-use

5 of 5

Customer support

5 of 5

February 2016

It is easy to grow the use of MasterControl as business needs grow

MasterControl provides the ability to create custom electronic forms; provides out of the box solutions such as: Audit, Supplier and Training. These are a few of the functions that have provided us the opportunity to use MasterControl to improve and automate many processes that use to be paper. MasterControl is also very focused on Voice of the Customer; there are multiple ways for users to provide enhancement requests; to provide feedback on new features and to let MasterControl know how they are doing as a business partner. The great thing is; the MasterControl team actually listens and acts on the VOC they receive. One big thing that I learned on my journey with MasterControl (I have been Sysadim for this product since 2005) is when you are setting the system up; think a bit into the future. When we setup MasterControl in 2005, the intent was to use it to control documents and training only. The use of MasterControl thru out our business grows more and more every year. (CAPA,NCP, Preventative Maint, SCAR, Audit, Supplier Qualification etc. )If I would have thought a bit into the future growth potential of the product; I would have set some things up a bit differently from the beginning to allow for better communication with SAP as an example. All things can be updated or changed; but it is so much nicer not to have to if it can be avoided. Training has also been key for us; obtaining training from MasterControl, attending their Summit, attending RUG's all help to learn how to get the best out of the software. The Summit and the RUG's also provide a great opportunity to meet and talk with other users and learn from them. We often think of ways to use MasterControl; that MasterControl has not thought of yet. Other software projects I have been involved in have taken a greater pool of resources to implement than MasterControl; this has also held true for validating upgrades of MasterControl.

September 2017

Betsy from Duke Translational Medicine Institute (DTMI)

Review Source: Capterra


Ease-of-use

5 of 5

Value for money

5 of 5

Customer support

5 of 5

Functionality

5 of 5

September 2017

Productive tool in a heavily regulated environment; nothing gets lost; intuitive interface.

Pros

Ease of use and seamless module integration all provided by one vendor. By having one vendor, one system, we always know where items are located and nothing gets lost.

Cons

Our View-Only users cannot sign/approve an inprocess document. It was recommended to us by a regulatory agency to have our individual user's CV and job description available and controlled online. These documents are to be reviewed yearly and signed by the user, the user's manager, and the training coordinator. However, there is a problem when the CV/JD belongs to a VO user. A lot of manual manipulation with the user's account has to occur to get this to work.

March 2018

Maria Luisa from Cosmetics, Drug and Medical Devices

Company Size: 51-200 employees

Review Source: Capterra


Ease-of-use

3 of 5

Value for money

4 of 5

Customer support

5 of 5

Functionality

4 of 5

March 2018

We being using MC for more than 10 years and it is great on Document Control.

Easy on the Process of Document change and control

Pros

People can see and perform what your Sysadmin allow them to. You can audit and report about anything within the system is you are consistent with your naming convention. The Tech Support service is great they are always available and willing to help you.

Cons

Our version is not to old. The biggest user complaint is related to perceiving the system "as not user friendly". It is disappointing to have these bugs that there is not much to do but work it around. So you do not have a clear explanation of it and much nor less to do into preventing these issues.

February 2017

Adrienne from Xeris Pharmaceuticals

Company Size: 11-50 employees

Review Source: Capterra


Ease-of-use

4 of 5

Value for money

4 of 5

Customer support

5 of 5

Functionality

4 of 5

February 2017

17 Feb. 17 MasterControl Review

MasterControl customer support has been very responsive in helping us get our instance of MasterControl up and running. I feel safe knowing our quality documents are in a secure, validated system that I can access almost anywhere, and that they sit in a system the FDA themselves use! As a pharma/device company, the FDA's seal of approval on an electronic QMS system means a lot to us! I'm glad our company chose the gold standard eQMS to implement.

Pros

It is secure - very validated and I feel safe using a system the FDA themselves use.

Cons

Both Java and Adobe must be up to date at all times and you can't use Chrome, and even then, we still have PDF publishing and opening errors.

July 2017

Julie from Sumco USA

Company Size: 501-1,000 employees

Review Source: Capterra


Ease-of-use

4 of 5

Value for money

5 of 5

Customer support

5 of 5

Functionality

4 of 5

July 2017

This software is so easy to use and manage. As the Sysadmin Master Control make me look good!

I always ace my audits and auditors are so impressed with our system!

Pros

Easy to configure and has the ability to customize a lot of features to your companies needs. Time for new users to feel comfortable in the system is pretty minimal considering how complex the system is as a whole.

Cons

Reporting is not good within the software but they are working on that, however it is easily retrievable from the database. Be sure to consider your set up carefully because it is difficult to change things already committed to the database. I inherited my system and would love to redo many things.