Über MasterControl Manufacturing Excellence
Die Software bietet eine vollständig papierlose und konforme Produktionsaufzeichnungsfunktionalität bietet, die die Erstellungs-, Überprüfungs- und Genehmigungszeiten von Dokumenten reduziert.
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.
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.
Nutzerbewertungen filtern (34)
The 'Adobe' of eQMS: Extremely powerful functionality with a learning curve well worth the effort.
Kommentare: 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.
Amazingly Robust, Compliant and Easy to Use
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.
Support services are excellent, but I feel I need to use them FAR too much
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
Antwort von MasterControl
vor 5 Jahren
Thank you for your feedback. We are always looking for ways to improve our product and processes and have been actively making improvements to our product development and quality assurance processes. We are confident that you will see a reduced number of defects in our latest and upcoming releases as well a reduction in time to resolution of the defects you do encounter. Your continued feedback is greatly appreciated and we look forward to your continued engagement with our Support and Services teams.
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.
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.
Possibilities are Endless!
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.
MasterControl software meets the regulatory requirement for automated systems.
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.
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
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.
Solves many issues, but has a big learning curve
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.
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.
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.
Our department (laboratory) has been with MasterControl since 2013 and basically everyone in the lab
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.
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.
We have compared MC to other document controls tools and MC have always been our choice.
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.
MasterControl Excels as an eQMS
Kommentare: ITxM purchased the MasterControl eQMS suite in 2004 and has been using the platform for Document Control, Training and Nonconformance Management. The software is very user friendly, and the Customer Support from Sales through Technical Account Management is exemplary. Upgrading the software has become easier and easier over the years, and we have never had any questions about the installation or validation of the system from any of our regulatory inspections; and we have lots of inspections, assessments and accreditations. The annual User Summit allows customers from all industries to come together and discuss best practices and share experiences. I would recommend MasterControl for any size company, both regulated and non-regulated. And if you don't have the internal resources to install the software, MasterControl can assist by hosting the software for you.
Easy to use and great customer support
Top dollar, but you get what you pay for.
It is easy to grow the use of MasterControl as business needs grow
Kommentare: MasterControl provides the ability to create custom electronic forms; provides out of the box solutions such as: Audit, Supplier and Training. These are a few of the functions that have provided us the opportunity to use MasterControl to improve and automate many processes that use to be paper. MasterControl is also very focused on Voice of the Customer; there are multiple ways for users to provide enhancement requests; to provide feedback on new features and to let MasterControl know how they are doing as a business partner. The great thing is; the MasterControl team actually listens and acts on the VOC they receive. One big thing that I learned on my journey with MasterControl (I have been Sysadim for this product since 2005) is when you are setting the system up; think a bit into the future. When we setup MasterControl in 2005, the intent was to use it to control documents and training only. The use of MasterControl thru out our business grows more and more every year. (CAPA,NCP, Preventative Maint, SCAR, Audit, Supplier Qualification etc. )If I would have thought a bit into the future growth potential of the product; I would have set some things up a bit differently from the beginning to allow for better communication with SAP as an example. All things can be updated or changed; but it is so much nicer not to have to if it can be avoided. Training has also been key for us; obtaining training from MasterControl, attending their Summit, attending RUG's all help to learn how to get the best out of the software. The Summit and the RUG's also provide a great opportunity to meet and talk with other users and learn from them. We often think of ways to use MasterControl; that MasterControl has not thought of yet. Other software projects I have been involved in have taken a greater pool of resources to implement than MasterControl; this has also held true for validating upgrades of MasterControl.
Productive tool in a heavily regulated environment; nothing gets lost; intuitive interface.
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.
We being using MC for more than 10 years and it is great on Document Control.
Kommentare: Easy on the Process of Document change and control
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.
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.
17 Feb. 17 MasterControl Review
Kommentare: 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.
This software is so easy to use and manage. As the Sysadmin Master Control make me look good!
Kommentare: 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.
Our experience has been overall very positive throughout selection to implementation.
Kommentare: 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.
Every person that I have ever dealt with or spoken to has been absolutely wonderful.
Kommentare: 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.
MasterControl has been a tremendous asset to both companies where I used the software.
Kommentare: 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.
MasterControl User for over 12 years
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.
Well-rounded, integrated, easy to use
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.
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.
Albemarle implementation of Documents, Training, PM, Calibration and Custom Forms.
Kommentare: Because it is solving a complex set of problems, MasterControl software is naturally complex. Once the initial learning curve is past (which is helped by the training and installation folks from MasterControl), the design of the software is understandable. Initial installation of the software allows for mass uploads of existing documents and data. When there are issues, caused by the software or by the customer, the support is second to none. Knowledgeable technicians are always available to help out, and with the help of WebEx and a telephone, it is like they are standing next to you. Support will generally solve a problem on the spot, and if that is not possible they will continue to follow up until a satisfactory solution is found. Documentation is good, with tools like checklists you can used when implementing a new module. A negative is the reporting tool. While I understand it is written so that a general non-programmer type can use it, more advanced options are not available. We have solved this issue by using Crystal Reports for the more complex issues. MasterControl does a good job of keeping track of what the current best practices are and integrating them into their software. If there are changes to the forms desired, they can be made by an experienced programmer, or can be contracted through MasterControl. The new forms design tool can make a non-programmer look like a professional for simple paper forms the user desires to turn electronic with routing, e-signatures and tracking completely available.
Pharmaceutical company using MasterControl for multiple quality systems
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