MasterControl Manufacturing Excellence

Avantages

The UI is very user friendly and intuitive

Inconvénients

Lack of a dark mode feature, themes were recently removed and a dark mode would be nice and easier on the eyes for those accustomed to it

Avantages

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.

Inconvénients

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.

Avantages

It is very helpful that Master Control has spent as much time as they have working with FDA professionals. Although my company is not in a Life Sciences industry, the set-up of the EBR has all of the elements that we need to make the FDA happy when they come to see it. It also makes us a better company, because all of our work on a product is easily accessible and we have good tracking capabilities.

Inconvénients

Integration was very difficult. I think Master Control has done a lot to refine the product since we started down this road, but there are still some things I need to be able to get into the EBR.

Avantages

I like that it is a great way to control documents and their revision history. Great collaboration tools for new documents.

Inconvénients

Needs better reporting and searching abilities

Avantages

I like the adaptability of the system, it's undergoing additional functionality additions which are a big help.

Inconvénients

I miss a change all shortcut feature in the builder environment.

Avantages

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.

Inconvénients

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.

Avantages

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.

Inconvénients

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.

Avantages

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!

Inconvénients

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.

Avantages

I love the ease of building production records and the integration between Mx and Qx.

Inconvénients

I think the flexibility of data entry corrections after a record is launched can be improved.

Alternatives envisagées 

Pourquoi choisir MasterControl Manufacturing Excellence 

Pourquoi passer à MasterControl Manufacturing Excellence

Avantages

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.

Inconvénients

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.

Avantages

MasterControl overall gives you all the work around for less paper and all traceability of your projects and systems

Inconvénients

I have yet to find something that I dislike about MasterControl.

Avantages

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.

Inconvénients

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.

Avantages

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.

Inconvénients

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.

Avantages

User friendly and very intuitive. Flexibility of templates and additional features make revisions easy and quickly issued.

Inconvénients

Could use a better revision history module to capture the template revisions inside the system.

Avantages

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.

Inconvénients

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.

Avantages

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

Inconvénients

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

Avantages

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).

Inconvénients

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.

Avantages

Ease of deployment across multiple global facilities

Inconvénients

None at this time we have been deploying various modules over the last 2 years with great success

Alternatives envisagées 

Pourquoi passer à MasterControl Manufacturing Excellence

Avantages

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.

Inconvénients

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.

Avantages

Ease of use. I was able to quickly figure out how to create a Master Template and a Production Record by following the handouts from MasterControl.

Inconvénients

There is no view only capability of production records that are "in-progress". There are functions outside of the Manufacturing Team who rely on real-time data from the production record to set up testing of samples. Because there is no view only of in-progress eBRs, this necessitates work arounds which adds work. The system requires that a User assigned to an Mx Operator Basic to also have a Basic Qx License. This interdependancy should be de-coupled as a User may require to perform full license rights in the Qx module but only Basic operator functions in Mx. I am a system administrator and there are no sys admin manuals or design specs or anything similar to the Documents and Process modules to help with administering the system. As a result, I am learning what is required as use errors occur. For example, how would an Admin know that the Trainee Infocard needs to be released before the User can work in Mx?

Avantages

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.

Inconvénients

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

Avantages

ease of use with template builder and deployment within our manufacturing environment

Inconvénients

integration still needs improvement in flexibility and features

Avantages

Ease of use for users, easy to follow and communicate issues on the floor

Inconvénients

Took a lot of time to set up, took several runs to work out the kinks

Avantages

Easy to use and great customer support

Inconvénients

Top dollar, but you get what you pay for.

Avantages

Ease of use dynamic and a scaleable to many sites

Inconvénients

Learning curve, system admins have to dive in to really understand

Avantages

Excellence document management and training system

Inconvénients

Inability to download jreport to an excel file

Avantages

Extremely easy for the end user to execute batch records and completely eliminates leaving blank spaces.

Inconvénients

Extracting data from the completed batch records via jReports is fairly complicated.

Avantages

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.

Inconvénients

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.

Avantages

Ease of use of the Batch Record designer tool and integration to the Qx solution for al things QA (Deviation, Events, Change Control, ect...

Inconvénients

Need a CMMS solution to round out package, but they have API that can plugin to antying.

Avantages

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.

Inconvénients

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.

Avantages

The product is easy to use. It cuts down on the GDP errors.

Inconvénients

The limitation on the lot number. We cannot have the system auto generate lot numbers for us because of the uniqueness and once a lot number has been created it cannot be changed. Doesn't allow for human error.

Avantages

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.

Inconvénients

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.

Avantages

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.

Inconvénients

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.

Avantages

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.

Inconvénients

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.

Avantages

The home page looks super organized, color coded, and well designed. In the tasks folder, the task names and due dates are clearly indicated. You can click on each link to follow through a series of steps and sign off on it.

Inconvénients

It is impossible to search any documents by key word, which is a major flaw. It is very difficult to find a needed document and add it to your task list. Even though the dashboard looks good, most of it is not intuitive.

Avantages

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

Inconvénients

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

Avantages

The ease and use of the software system.

Inconvénients

The inability to run reports with the information needed.

Avantages

I like that it is an established software used to control documents. Once you get the hang of it, it's quite easy to use.

Inconvénients

As I mentioned, there is a slight learning curve to using MasterControl for your specific needs. However; once you familiarize yourself with the workflow and the specific buttons/fields to fill out, it becomes quite seamless.

Avantages

We were already a QX user so it made sense for us to move forward with MX. The integration was easy between both modules.

Inconvénients

There are some features that would be helpful that aren’t available, however there are continual updates

Avantages

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

Inconvénients

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.

Avantages

What I like most about master control mx is the ability to manage, track, and error proof the manufacturing process from beginning to end.

Inconvénients

I have some minor frustrations with the UX. The biggest annoyance is having to publish a template to test it.

Avantages

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.

Inconvénients

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.

Avantages

I've used MasterControl in office settings in the past. This software is very powerful when it comes to data processing and document control. The latest version, in fact, is quite user friendly. MasterControl also offers integrated database features that can be used for PM and Validation tracking.

Inconvénients

MasterControl is so powerful that at first it's very confusing to use. Once you get the hang of it, however, you'll find that you can process documents with relative ease.

Avantages

Ease of use. Scalability. Versatility. UX. Ability to integrate with non-MC platforms.

Inconvénients

I wish leveraging metadata behind out executed batch records was easier. Mx Insights should help.

Avantages

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

Inconvénients

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

Avantages

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

Inconvénients

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.

Avantages

This software is easy to use and easy to understand

Inconvénients

Sometimes master control tends to time me out