MasterControl Manufacturing Excellence Erfahrungen

Vorteile

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

Nachteile

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

Vorteile

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.

Nachteile

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.

Vorteile

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.

Nachteile

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?

Vorteile

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.

Nachteile

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.

Vorteile

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.

Nachteile

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.

Vorteile

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.

Nachteile

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.

Vorteile

Ease of deployment across multiple global facilities

Nachteile

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

In Betracht gezogene Alternativen

Quality Management Software, ETQ Reliance und QCBD

Gründe für den Wechsel zu MasterControl Manufacturing Excellence

Workflows, Modules, Customer Service

Vorteile

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.

Nachteile

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.

Vorteile

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

Nachteile

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.

Vorteile

Reduction in errors, aids in investigations and auditing, and improves our production process.

Nachteile

Having to insert a step at the bottom of a template and slowly move it to the top.

Vorteile

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.

Nachteile

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.

Vorteile

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.

Nachteile

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.

Vorteile

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.

Nachteile

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.

Vorteile

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

Nachteile

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.

Vorteile

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.

Nachteile

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.

Vorteile

The ease and use of the software system.

Nachteile

The inability to run reports with the information needed.

Vorteile

Excellence document management and training system

Nachteile

Inability to download jreport to an excel file

Vorteile

User friendly UI. Eliminates the need to paper documents and helps streamline manufacturing and training tasks. They are constantly improved based on customer feedback

Nachteile

Some functions for the builders are limited. Not all actions are straightforward, and some workflows can become complicated.

Vorteile

This software is easy to use and easy to understand

Nachteile

Sometimes master control tends to time me out

Vorteile

The batch record review time is cut in 1/2.No longer need to guess hand writing .

Nachteile

Revision of master template in the producing vault doesn’t show redline

Vorteile

It will be easy to integrate with our existing QMS system and user can easily build template

Nachteile

The cost of the product is quite high and it is difficult to get buy in from upper management

Vorteile

It is very easy to use and I am able to easily keep track of training completed in my comoany

Nachteile

I think that there are a few features that could be more user friendly

Vorteile

Paper less & better control of our process and quality system

Nachteile

To add more configuration options so it can support our QC department operation

Vorteile

Easy to use, clean interface makes it simple for operators

Nachteile

Cannot track changes to docs or records within MC