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.
Ann Marie from WD-40 Company
Specialty: Consumer Products
Employees number: 501-1,000 employees
Good security. Cloud based. Mobile access.
Variety of modules within one software; Document Control, Audit, Supplier, Bill of Materials, Electronic Forms. Custom Forms, Reports, Training and more. Development listens to our ideas for improvement.
Huge time saver.
Depending on number of modules used, could be more user friendly. They are working on this.
Validation is timely. New validation risk based process is due soon.
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.
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.
Sharon from Lannett Company, Inc.
Employees number: 1,001-5,000 employees
I love the MasterControl Application. I really like the people and the support
The flexibility of the application and usability. The software is easy to use, manage, and understand. The users love it too.
The LDAP. I will it was more robust and more flexible where you do not have enable and disable users all of the time
Maria Luisa from Cosmetics, Drug and Medical Devices
Employees number: 51-200 employees
Easy on the Process of Document change and control
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.
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.
Meghan from University of Texas
It's very easy to track who has read document. Has a sign off function. Easy to upload documents into program.
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
Kim from Biotechnology
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.
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.
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!
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.
Michelle from Cambrex High Point
Efficency, increased compliance, increased visibility to users, ability to review and approve docs electronically on a web interface.
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.
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.
Aida from Ancestry.com
Having all our quality documents, training, BOM and Suppliers in one SW makes quality management easier.
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.
The lack of functionality that allows multiple users to simultaneously "edit/collaborate" on the same document.
Paul from CooperSurgical
Employees number: 501-1,000 employees
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.
Ease of use, user configurable, connection between their modules and the ability to create form workflows.
The need to upgrade to address bug fixes, having to upgrade to incorporate new features, User Training and validation time.
Jill from Cypress Medical Products, LLC
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.
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.
Betsy from Duke Translational Medicine Institute (DTMI)
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.
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.
Gen from Grand River Aseptic Manufacturing
Employees number: 201-500 employees
Clean look, excellent customer service from the tech services groups, but their hands are tied far too much.
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
Response: MasterControl, MasterControl Inc.
Date: 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
Employees number: 5,001-10,000 employees
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.
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.
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.
Kate from Array Biopharma
Employees number: 201-500 employees
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
Customization costs seem high for some requests (report changes)
Additional costs for adding business units, sites
Crystal from McKesson
Employees number: 1,001-5,000 employees
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.
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.
Hetty Jane from Stryker
Ease of use and navigation for the end user. Minimimal admin staff needed. Houses all our Quality System Documents in one place.
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.
Thomas from Wright Medical Group, N.V.
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.
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.
Matthew from OrthoPediatrics
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.
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.
Lillian from Maxtec LLC
Employees number: 51-200 employees
Increased productivity, compliance, visibility, and capability.
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.
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.
Leslie from Wright Medical
Assigning Training - no longer done manually. Easily run reports to perform audits.
The reporting that can be pulled from the system. As well as taking human error away from archiving the previous revisions.
At the beginning you feel a little overwhelmed, but having good work instructions is the key for your internal customers.