MasterControl Quality Excellence

Pros

I love that all of MasterControl's modules are connected. Document management, training management, and Quality Event Management all talk to one another and help to streamline our processes. It's also very easy for basic users to learn.

Cons

My biggest complaint has been the lack of flexibility in Quality Event workflows. This is being solved by the new Advanced QEM product, which I'm super excited about.

Alternatives Considered

Reasons for Switching to MasterControl Quality Excellence

Pros

Easy to use and users are able to find what they’re looking for In real time

Cons

Publishing and search Still needs to be improved we have a lot of problems with publishing documents

Alternatives Considered

Reasons for Choosing MasterControl Quality Excellence

Switched From

Reasons for Switching to MasterControl Quality Excellence

Pros

Preconfigured process forms for CAPA, Nonconformance, OOS, etc., along with the ability to create custom 'eForms' to define specific process needs.

Cons

The lack of dependencies when using eForms. This, however, is now being addressed in MasterControl's new AQEM platform.

Alternatives Considered

Reasons for Switching to MasterControl Quality Excellence

Pros

It gave us a way to escape paper event management forms and Excel spreadsheets.

Cons

It doesn't integrate well with other modules, its cumbersome, its difficult to setup.

Pros

I love building workflows, easy document management, and automated training management hubs. It is taking a lot of paper being wasted and having documents easier to find and in one place.

Cons

I would say AQEM needs a tad more work but I absolutely love how easier it will be for electronic forms once they fix some humps.

Alternatives Considered

Reasons for Choosing MasterControl Quality Excellence

Switched From

Reasons for Switching to MasterControl Quality Excellence

Pros

The documents module is the best piece of the suite. It allows you to create any kind of document needed from your work environment. The workflows are customizable to your type of work. I don't work in a pharmaceutical regulated area but I can create the quality management system that works for me with this product.

Cons

The Jreports portion of this product does not live up to the expectations and performance level of the rest of the suite. The reports are clunky and difficult to create and personalize.

Pros

Document management is simple and effective.

Cons

I don't have many other eQMS to compare to, but I would say that the system is not as intuitive as it maybe could be. We have a lot of users who do find navigation of the system overall to be difficult.

Pros

It is set up to facilitate the quality process for you. If team members go into the program (or click on a link from their email) and complete the tasks, the system takes care of itself.

Cons

It is built for the most robust quality system. For some industries/customers that may be too much, but they are addressing it now through their new "lite" forms.

Alternatives Considered

Reasons for Switching to MasterControl Quality Excellence

Pros

This program makes document control so much easier for my company. The way you can search and collaborate with people in the company is much easier along with the tracking of all revisions is so helpful.

Cons

That you do have to wait for people sometimes to move a task along depending on how you have it built. I also wish there was a date of when the InfoCard was approved on the main screen instead of having to go into the InfoCard itself or looking at the highest REV of the document.

Pros

The customization. MC is a useful quality system for every industry type and size.

Cons

User friendliness isn't what MC is known for, so it is important to have dependable contacts within a company to help users navigate.

Pros

Moving our document change review and deviation processes from paper based into MasterControl has been an absolute game changer - the risk of losing records has reduced dramatically. We now have much greater visibility at which step in a process a document change is and who is involved in deviations.

Cons

Some of the user functionality can be not entirely intuitive, making it slightly more difficult to navigate for users who use the system only occasionally.

Pros

The system is very easy to access and use. It allows for an easy audit trail of users and during the construction of templates edits can easily be made and approved by several users before release. During manufacture the ability to force steps to be filled in by an operator before moving on is huge. Reviews are so much quicker than before and we have beat many targets due to this.

Cons

In my role there aren't currently any aspects of MX that cause an issue.

Pros

It’s an all-in-one out of the box solution

Cons

It can be inflexible and it’s not the most user friendly

Pros

Everything is in one place and is auditable

Cons

It is not easy to train out, nit an easy user interface

Pros

It is easier to maintain than a bespoke QMS

Cons

The lack of configurability pre AQEM which we haven’t implemented yet

Pros

The fact that it brought standardization of quality processes into a global system used world wide.

Cons

Performance issues whilst mass uploads or mass downloads

Pros

We currently use docs and training and having all of that automated has been super helpful. Tracking metrics around training and docs has been much easier with data that can be downloaded at any time. Time spent chasing down training has been significantly reduced and has made the quality team more effective overall.

Cons

With the modules we currently use, I wish classes worked a little better. They are a bit difficult to set up and don't seem to integrate well with employee calendars, so extra invites are sent outside of MasterControl.

Pros

Training module features for creating exams and use of classes.

Cons

Defect that happen that cause system not to function correctly. For example, completed training being relaunched.

Pros

As Document Control I like the most that you can quickly search for documents and track packets. I like a fact that we can also update documents at step 2 Doc Control and fix format etc.

Cons

I do not like that there is no notification whenever the packet is signed off by originator at collaboration step (after update).

Pros

It is much easier to manage the documentation. Paper records easily get lost.

Cons

The least appealing part is the cost. The product is quite expensive but we believe it is worth it.

Pros

Its a one stop shop for your quality manangement systems.

Cons

The Qx module does cotain some ridged enhanced forms

Pros

MasterControl offers a robust InfoCard system that spans across various modules, enhancing the overall user experience. Document InfoCards effectively consolidate document files and associated metadata, providing a comprehensive overview, including document number, type, subtype, and custom fields

Cons

Unfortunately, my experience with jReports leaves much to be desired, particularly in its ability to handle large volumes of data. As someone who regularly deals with datasets comprising millions of lines, I found JReports to be quite inadequate in meeting the demands of such extensive data processing.

Pros

Switching from paper based training to electronic MasterControl training module made a big difference in having a fast overview on the training status for employees, would not go back to paper never.

Cons

No complete compliance training report is available, you have to browse multiple default Jreports, ended up creating a custom report with the aid of MC.

Pros

Ease to use and customize, being able to track progress and audit trail

Cons

It took a bit of time to create the base line for migrating all doc from previous platform

Alternatives Considered

Switched From

Reasons for Switching to MasterControl Quality Excellence

Pros

The integration with business processes is worth every penny. Plus this company listens to their users. They are all about the customer voice.

Cons

The process forms, which will be more flexible with the AQEM launch. The Audit trail report.

Pros

It consolidates all of our companies information into one location and everything is neatly tied together.

Cons

The fact that the use of most symbols can cause unwanted defects.

Pros

Documents and Training is very heavily used at our organization and saves a ton of time and money. Our company also uses the process module for CAPAs and Change Control. Once it's implemented, it's easy to use and train users.

Cons

The process module is not very customizable, and the time and cost associated with implementation is very high.

Pros

MasterControl Quality Excellence (Qx) gives us the flexibility as a global organization to configure what we need, as we need it, without needing to edit code or re-validate the system. It allows us to manage compliance and track documents (with revision and access control), training, and quality events. In addition the system is hosted in the cloud, so we do not need to maintain our own infrastructure or IT team solely for the software. By being in the cloud, we receive frequent quarterly upgrades with new features, monthly defect patches, and global 24/7 availability. We also utilize the VxT validation tool, which cuts our quarterly upgrade validation time down to hours, and the customer support team is top-notch.

Cons

There are some quirks to the system that take some learning, but MasterControl has developed an excellent self-study library of courses to help. In addition, the older quality events module presented some configuration limitations that required us to adapt our processes to match MasterControl rather than the other way around. Fortunately, MasterControl's replacement of this module, Advanced Quality Event Management, just launched in 2024 and is alleviating this pain point.

Pros

Quality Excellence is an extremely robust and customizable system that allows the users to create custom workflows for their document control processes. These workflows can be generalized for maximum usage across documents or specialized for an almost hands-off experience in the system.

Cons

The nuance of using the system can have a fairly steep learning curve. Currently, we are still finding little quirks in the system that can't be called generally good or bad. Just the fact that we are still learning different facets of the system tells how much there is to learn when using the system.

Alternatives Considered

Reasons for Switching to MasterControl Quality Excellence

Pros

I love having a system that is digital (coming from someone who's always worked with a paper based system). The ease of routing all document types in all modules is one of my favorite features specifically for a company that has multiple sites)

Cons

Some of the pain points are the cost of licensing, not having the ability for multiple collaborators to edit the same document simultaneously, and search functionality being tough for users who aren't as familiar with document numbers/names.

Pros

Provides a wide range of modules, each of which are highly configurable.

Cons

Platform is not the most intuitive to use, so can take a while for Users to learn.

Pros

It is easy to manage documents and quality issues. In particular, the "Report function" can be customized and used, so it is possible to grasp the real-time status.

Cons

It's inconvenient that I can't set up in detail during my absence. I wish I could do each of the absent settings for each permission.

Pros

OBI has been using MasterControl since 2010. It was challenging going from paper to electronic, but I have a sense of peace knowing that everyone should receive what training, access to documents, and said training, etc. I have scheduled reports and times when I audit training. Access and ability has saved me.

Cons

Lack of transparency. As a former Information Technology staff, I understand the importance of getting things (fixing issues) done now. Unfortunately, we forget to communicate or consider how certain changes may impact the organization.

Pros

I like the seamless integration between the Documents and Training modules. We have totally eliminated paper training records, eliminated manual record tracking and filing, and we have ready access to all required records during audits and inspections. As FDA registered facilities we needed FDA part 11 compliance and audit trails. MasterControl has given us all these capabilities in an intuitive and easy to use paltform for all users.

Cons

We had to do our homework when initially configuring the software to understand how to make the right decisions and allow the system to scale with our own evolution and growth. We knew where we wanted to end up, but didn't understand all the new terminology, or exactly how the system worked. We hired a third-party consultant recommended by another MasterControl user and leveraged their expertise to bridge the knowledge gap between us and MasterControl. The initial configuration took longer than we originally planned, but we ended up with a configuration that works very well for us.

Pros

Having everything in one place makes it easier to manage the document management tasks

Cons

Sometimes there are parts of the system that are unable to be edited/updates and this can limit how we schedule our tasks

Pros

I love that fact that it is so customizable.

Cons

Compared to everything else I have seen- there are no real cons. Perhaps the need for users to be somewhat computer literate.

Pros

Good for capturing data in an auditable system for the production of food and pharmaceuticals, and life sciences.

Cons

Issues with the systems are not addressed in a timely manner and are frequent. The system has quite a few bugs, like not loading pages until you click "reload this page" in your browser.

Pros

Easy to use for end users and admins
I like easy configuration of system and the flexibility

Cons

Reporting is a little bit difficult, overview on quality tasks is difficult

Pros

We are able to manage documents and training again as this was not workable on paper anymore.

Cons

Some reporting functions are still not that easy to use (for example tracking pending tasks)

Pros

Doc management js ok but the collaboration area needs improvement

Cons

Control copy and collaboration needs more features but I know you guys will get there

Pros

Everything is on one place, it's easy to control documents and manage training

Cons

It's quite clunky sometimes, for example rejecting documents, managing fbs forms, audit module on it's own

Pros

Master Control provides great costumer services. Everything from the kick off to going live is smooth. Very helpful with the new aproaches to the old processes. All questions are answered quickly and in quality. It is very user friendly platform, easy to use and manage.

Cons

As a global service sometimes it is harder to get a new needed for specific company feature added. But not impossible.

Pros

All in one and linkage between modules, job codes etc

Cons

Nomenclature is hard to understand but once using it’s fine

Pros

MC is willing to continue to update and upgrade their tool.

Cons

Attrition of Tech Support causes some inconsistencies in support.

Pros

Easy to customise according to your needs.

Cons

Not intuitive for first time users of
New processes.

Pros

Doc Management, Training and some aspects of Process module.

Cons

Majority of the features linked to Supplier Management, Audits, Risk. User Management needs improvement. Analytics. Registrations.

Pros

I love the learning and development section of the MC the website. I love how all features can be integrated.

Cons

End users struggle. You need to be using MC daily to appreciate/understand. Dashboard can be overwhelming. Wish the learning and development section from website could be easily accessed from MC app.

Pros

I really enjoy the community provided for extended learning and comparing with other professionals. It's a well-rounded, multi-faceted way to keep documents on hand and organized for multiple purposes across many departments. As a doc admin, this makes my job much easier and organization is imperative for my role.

Cons

Truthfully, I cannot think of what I dislike about the program. With my position, it's made things much easier.

Pros

Workflow flexibility and the validation process.

Cons

Reporting still lacks flexibility for end users.

Pros

That all the Quality processes and docs of your company are fully accessible everywhere. Internet connection is the only thing you need.

Cons

There are few constraints and defects using the out of the box processes workflows. Some customizations are required.