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.
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.
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
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.
Desiree from U. S. Army Public Health Center
Employees number: 10,000+ employees
I am no longer a paper-pusher and my job has grown tremdously supporting several units and locations.
The system handles everything, and in one place and it has complete traceability. It is web based, so you don't have to install it on the users computer.
Once something is created and in there, it's there forever. I have had people who do not know what they are doing create something and even though you can 'delete' it just moves to a deleted vault and never is really deleted.
Ryan from Cochlear Americas
Employees number: 501-1,000 employees
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.
There is room for improvement in reporting. Master Control has already identified this gap and planned to include in future releases.
Linda from Adventist- Florida Hospital
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).
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.
Julie from Sumco USA
Employees number: 501-1,000 employees
I always ace my audits and auditors are so impressed with our system!
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.
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.
Patrick from Antares Pharma
Employees number: 51-200 employees
The ease of use for the end user, the customizability of the software you are not limited to what they allow you to do, you have a good free range of features you can manipulate.
As a longtime customer, I would like a little let us say freedom within the system to allow me to do a little in-depth customization and access to a different level of technical support, I'm not a noob here.
Adrienne from Xeris Pharmaceuticals
Employees number: 11-50 employees
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.
It is secure - very validated and I feel safe using a system the FDA themselves use.
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.
I would recommend making a validation outline for clients with hosted solutions to follow, to make it easier for them to go through the validation process. I have an example I'll be sharing with Alex Butler.