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.

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.

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.

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.

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.

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.

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.

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.

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.

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.