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Was ist MasterControl Quality Excellence?
Die MasterControl-Plattform enthält Dutzende von Lösungen, mit denen Unternehmen einige der strengsten regulatorischen Anforderungen der Welt erfüllen. MasterControl wurde von erfahrenen Branchenveteranen entwickelt, die die Herausforderungen von Unternehmen in den Biowissenschaften und anderen regulierten Umgebungen verstehen. Die Software ist auf die Einhaltung von Vorschriften der US-Behörde für Lebens- und Arzneimittel und der Europäischen Arzneimittel-Agentur sowie internationalen Normen wie ISO und ICH zugeschnitten.
Wer verwendet MasterControl Quality Excellence?
Primäre Zielmärkte sind Qualitätsmanager in Life-Science-Unternehmen, die mit streng regulierten Produkten zu tun haben.
Wo kann MasterControl Quality Excellence bereitgestellt werden?
Über den Anbieter
- MasterControl
- Ansässig in Salt Lake City, USA
- 1994 gegründet
Support für MasterControl Quality Excellence
- Telefon-Support
Sprachen
Englisch
MasterControl Quality Excellence Kosten
Startpreis:
- Keine kostenlose Testversion
- Keine Gratisversion
MasterControl Quality Excellence bietet keine Gratisversion und keine kostenlose Testversion. Die kostenpflichtige Version von MasterControl Quality Excellence ist ab 25.000,00 $/Jahr verfügbar.
PreismodelleÜber den Anbieter
- MasterControl
- Ansässig in Salt Lake City, USA
- 1994 gegründet
Support für MasterControl Quality Excellence
- Telefon-Support
Sprachen
Englisch
MasterControl Quality Excellence – Videos und Bilder
MasterControl Quality Excellence Funktionen
Bewertungen über MasterControl Quality Excellence
Implementation of Doc and Training
Feature Rich and Compliant eQMS
Kommentare: Like many MC users, we started with doc control and training. This allows us to technologically link the two processes together. New revision to an SOP? Training automatedly is sent to users. Want to ensure training is complete before release? MC can delay the release until a specified amount of training is completed. MC also provides QEM solutions which can further support all other aspects of the QMS.
Vorteile:
MC provides a solid framework for any QMS. You are able to adapt any process into MC with minimal modification. MC is also a fully integrated platform and nothing in the software works in isolation. Training, document control, QEM; all of it works together.
Nachteile:
MasterControl isn't intuitive. There is a lot of training that needs to go into its use, especially if the person is doing more than just accessing SOP and performing training. However, MC does provide A LOT of training resources which takes some of the burden off of admins.
Veranova -QE
Kommentare: I always use master control every day in my scope of work. I am the trainer for the facilities and users. Found it very simple to work.
Vorteile:
Easy to use and users are able to find what they’re looking for In real time
Nachteile:
Publishing and search Still needs to be improved we have a lot of problems with publishing documents
In Betracht gezogene Alternativen: Veeva Vault
Warum MasterControl Quality Excellence gewählt wurde: We won our solution and removed from on premise to the cloud
Zuvor genutzte Software: Dot Compliance
Gründe für den Wechsel zu MasterControl Quality Excellence: Customer support It’s always available 24 seven and response times it seems to be improved
MasterControl
Kommentare: Frustrating more than anything, primarily relating the cons listed. I inherited the system in a state that would have worked well on a small scale during initial adoption, but was completely unmanageable at scale. After years of cleanup, it's working better for us, but the system still leaves much to be desired, and after 5+ years of using it 5 days/week, I can tell you not a day has gone by that we don't experience a bug. Fortunately, they're rarely critical. As stated in the cons, it gets a passable performance, though it could be easily improved if they took the time to do so.
Vorteile:
The best feature of MasterControl as a whole is the process module. Process module allows custom electronic form development and allows custom routing for those forms. While it can be improved, it's a great tool, and in my opinion, MasterControl and most customers are not realizing its potential, but we do. 80% of our records are generated in the process module.
Nachteile:
There are a number of factors that all seem to coalesce to create a system that can easily become unmanageable. Those are poor documentation related to best practices that isn't easy to find or well communicated by MasterControl, lackluster support, and an already confusing user platform with a generally poor user experience. There are number of small improvements that could be made that would greatly improve user experience, but MasterControl rarely seems to develop enhancements. I've used several versions over the years, and in most cases, the user experience got worse, not better. Providing clearer/more readily accessible documentation, better support and recommendations for admins during initial setup, and making some small quality of life changes would really go a long way. With that said, that software meets all baseline requirements in satisfactory way.
7 successful years with MasterControl
Kommentare: We have been using MasterControl since 2016 and since then we have NEVER received an Audit finding (neither by our ~global customers, nor any regulatory body like DQS, district government or even FDA).I feel secure and relaxed, knowing our quality documents are in a secure, validated system that I can access from anywhere, and that they sit in a system even our customers and the regulators themselves are utilizing!As a Pharma/MedTech logistics company, an electronic QMS system is a necessity and we are looking forward to utilizing more innovations with our imminent move to the MasterControl Cloud, especially because of the very promising AQEM solution!
Vorteile:
Document Collaborations, Deviation/CAPA forms, training structure (Course/Exam/JobCodes/Trainee) is excellent
Nachteile:
Too many bugs in necessary utilities like Action Items and Extension Requests, Management of Change module not up to our quality standards, Jreports are very user unfriendly
In Betracht gezogene Alternativen: Veeva Vault
Gründe für den Wechsel zu MasterControl Quality Excellence: MasterControl was much cheaper than the others and offered a comprehensive "all in one" solution that we needed
Implementation of Doc and Training
Kommentare:
We had a paper training process and used PDM for document control, which was not ideal because the user had access to prior control document revisions. Once we were able to inventory our procedures and forms, we were able to implement a solution that is long term sustainable
We know we hit the jackpot, when the [SENSITIVE CONTENT HIDDEN] of the company said that was able to do training very easily because the document was attached to the training. He didn't need to attend training on how to use the software to figure out how do complete his procedure assignment training.
Vorteile:
1) For the user, it was very easy for the user to complete training. Steps are very intuitive 2) Implemented a document control solution that prohibited certain users from seeing archived versions of the documents. 3) each to find document by searching by datacard elements
Nachteile:
didn't set up data card structure as best that we could.
In Betracht gezogene Alternativen: TrackWise
Warum MasterControl Quality Excellence gewählt wurde: paper controlled process for training and change control that was not regulatory compliant and couldn't be sustained.
Zuvor genutzte Software: SolidWorks Enterprise PDM
Gründe für den Wechsel zu MasterControl Quality Excellence: functionality