MasterControl Quality Management System (QMS) software


38 reviews(4.5/5)
38 reviews(4.5/5)

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.

Supported Operating System(s):
Mac OS , Web browser (OS agnostic) , Windows 10

38 Reviews of MasterControl Quality Management System (QMS)

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  • Verified Reviewer

    July 2018

    Makes document management and sharing easy and centralized.

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money
    Pros

    Anyone at the company can see and access relevant documents without having to keep paper. Great if you like the picture-based layout

    Cons

    The icon/picture-based layout is great if that's the way your mind works, but for me personally I can sort through information better if it is text-based.

    This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
    Review Source: Capterra
  • Sharon from Lannett Company

    Number of employees: 1,001-5,000 employees

    June 2018

    Excellent

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money

    Automation and the removal of paper process in which paper can be lost

    Pros

    The software is flexible and intuitive. It is easy to use and understand. It is a very comprehensive system.

    Cons

    Defects can cause issues and cause users frustration. Some times the business does not plan out the best use for the application or process

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Verified Reviewer

    June 2018

    Great Document Control System for Developed Companies

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money
    Pros

    I like that this software can be custom tailored to fit your organization. There are also options to add other modules that all link to each other so it is easy to add on features if needed. Keeps track of all users training records

    Cons

    Not the most user friendly for people who lack computer skills and technical proficiency. Very expensive

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Verified Reviewer

    April 2018

    Excellent control of documents ...

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money
    Pros

    The best thing about the program is the ability to track documents and identify whether the document was read or not.

    Cons

    It is not easy to use for the average user and its cost is very high considering that there are similar programs at a much lower cost.

    This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
    Review Source: Capterra
  • Jonelene from Pace Sensors Limited

    Specialty: Electronics

    Number of employees: 11-50 employees

    April 2018

    Document control never been as easy

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money
    Pros

    This QMS help us obtain our ISO certificate 2 years ago. With this approval on documents is on track and tractability is perfect.

    Cons

    We have on-site set up and only on our office can be access. It is a security but will be more flexible if it is cloud base.

    This reviewer was invited by us to submit an honest review and offered a nominal incentive as a thank you.
    Review Source
  • Verified Reviewer

    Number of employees: 51-200 employees

    April 2018

    Well-rounded, integrated, easy to use

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money
    Pros

    The integration between documents, processes, training etc is seamless. We came form paper-based manual systems and bringing our document system to MasterControl was pretty dang easy and I did it with a very small group. Remarkable customer service/tech support.

    Cons

    Expensive. My old training software was 1/3rd of the price and had pretty similar features. With that being said, I don't know if I could switch. The pros outweigh the costs for me, but it really is an expensive product.

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Maria Luisa from Cosmetics, Drug and Medical Devices

    Number of employees: 51-200 employees

    March 2018

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

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money

    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.

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Meghan from University of Texas

    February 2018

    Excellent document control

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money
    Pros

    It's very easy to track who has read document. Has a sign off function. Easy to upload documents into program.

    Cons

    Not very user friendly at times. Search function can be off. Often users are unable to open the program if they're not in the correct internet version

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Kim from Biotechnology

    January 2018

    Solves many issues, but has a big learning curve

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money
    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.

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Verified Reviewer

    October 2017

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

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money
    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.

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Michelle from Cambrex High Point

    September 2017

    Our experience has been overall very positive throughout selection to implementation.

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money

    Efficency, increased compliance, increased visibility to users, ability to review and approve docs electronically on a web interface.

    Pros

    What I like most about this software is that it provides all users with documents they need but with the ability for the software to be configured to prevent certain users from modifying these documents. In a paper system, this had to be managed very closely by QA and users would have to request to see certain project documents. Now they can see them when they want with no need to wait for QA to provide a copy.

    Cons

    My least like feature is the out of office notification. It does not always work as easily as it should. However, there are work arounds that can be done to push documents through a route.

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Aida from Ancestry.com

    September 2017

    MasterControl is an excellent tool with an outstanding customer care team!

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money

    Having all our quality documents, training, BOM and Suppliers in one SW makes quality management easier.

    Pros

    The user interface is easy to navigate. There are countless configuration possibilities within the software making it customizable to meet various business needs. The interconnectedness of the Document and Training Modules makes training management easy.

    Cons

    The lack of functionality that allows multiple users to simultaneously "edit/collaborate" on the same document.

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Paul from CooperSurgical

    Number of employees: 501-1,000 employees

    September 2017

    MasterControl has been a tremendous asset to both companies where I used the software.

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money

    Superior document control, use of Forms within process workflows and training connection to documents. The software has been a great help with remaining compliant and addressing ISO and FDA audits. The Process Module allows us to create form workflows to address our business requirements.

    Pros

    Ease of use, user configurable, connection between their modules and the ability to create form workflows.

    Cons

    The need to upgrade to address bug fixes, having to upgrade to incorporate new features, User Training and validation time.

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Jill from Cypress Medical Products, LLC

    September 2017

    MasterControl software meets the regulatory requirement for automated systems.

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money
    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.

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Betsy from Duke Translational Medicine Institute (DTMI)

    September 2017

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

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money
    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.

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Gen from Grand River Aseptic Manufacturing

    Number of employees: 201-500 employees

    September 2017

    Support services are excellent, but I feel I need to use them FAR too much

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money
    Pros

    Clean look, excellent customer service from the tech services groups, but their hands are tied far too much.

    Cons

    SO MANY BUGS. And several times I have been told that the bugs will not be resolved because they are not high enough priority. Sales groups (who I was told to contact to push the issue) do not respond. I do not feel comfortable executing a new module when the training module essentially cannot be trusted to work with the document module

    This review was submitted organically. No incentive was offered
    Review Source: Capterra

    Response: MasterControl, MasterControl Inc.

    September 2017

    Thank you for your feedback. We are always looking for ways to improve our product and processes and have been actively making improvements to our product development and quality assurance processes. We are confident that you will see a reduced number of defects in our latest and upcoming releases as well a reduction in time to resolution of the defects you do encounter. Your continued feedback is greatly appreciated and we look forward to your continued engagement with our Support and Services teams.

  • Joanne from UC San Francisco Medical Center

    Number of employees: 5,001-10,000 employees

    September 2017

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

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money

    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.

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Kate from Array Biopharma

    Number of employees: 201-500 employees

    September 2017

    Pharmaceutical company using MasterControl for multiple quality systems

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money
    Pros

    Modules that connect to one another - documents, training, suppliers, audits
    Fairly easy to configure to specific quality needs
    MasterControl provides excellent support documentation including validation

    Cons

    Customization costs seem high for some requests (report changes)
    Additional costs for adding business units, sites

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Crystal from McKesson

    Number of employees: 1,001-5,000 employees

    September 2017

    Possibilities are Endless!

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money
    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.

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
  • Hetty Jane from Stryker

    September 2017

    MasterControl provides the ability to control our documents in one platform.

    Ease-of-use
    Functionality
    Quality
    Support
    Value for Money
    Pros

    Ease of use and navigation for the end user. Minimimal admin staff needed. Houses all our Quality System Documents in one place.

    Cons

    Our earlier version has some bugs in it which has caused some issues when implementing the review process. My understanding is that these bugs have been worked out in later versions.

    This review was submitted organically. No incentive was offered
    Review Source: Capterra
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