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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
MasterControl Quality Management system
Kommentare: MasterControl has allowed us to replace book shelves of policy binders, file cabinets of employee training and competency forms. Staff can all access the same document at the same time instead of waiting for the binder to be free. Regulatory requirements are easy to track within the system.
Vorteile:
This system is flexible enough for a any regulated industry. It includes a document management module, employee training module, Quality module that included Deviations, CAPA, Change Control, non-Conformance; Quality, risk management, etc.
Nachteile:
The suite of modules has not been certified as HIPAA compliant, except for the Documents module. Full HIPAA compliance is on their timeline for 3rd quarter 2020.
Quality Changes Everything
Kommentare: We are currently upgrading from and older version of MasterControl to their new cloud based offering and the updates to the training module will make keeping track of employees training status much quicker and easier.
Vorteile:
The user interface makes this software so much easier to use than others that I have tried, even the most technophobic people in our organisation are willing and able to get on with MasterControl
Nachteile:
There are a couple of areas where we would like to hide or remove buttons so that they don't confuse the end user, but I'm sure these suggestions will be looked at the way MasterControl evaluate all customer feedback and will eventually be implemented.
In Betracht gezogene Alternativen: Veeva Vault und Ideagen Quality Management
Gründe für den Wechsel zu MasterControl Quality Excellence: Offered everything that we needed in a much cleaner and easier to use package
Decent Document/Training module
Kommentare: MasterControl works as a document management and training module. It is not as robust as I would like but it is relatively easy to work with. The customer service is above average.
Vorteile:
The strength of MasterControl is that it is easy to configure. For documents and training someone new to MasterControl can take the free online training and be at a module admin level in 2-3 months. For the most part changes do not need to be validated because the configurations are so limited that the OQ/PQ can justify functions.
Nachteile:
The weakness in MasterControl is that the configurations are so limited. There are often times when you expect the system to be able to do something only to find out that it is not fully capable of what you expected. And example would be setting up prerequisite courses. This would be a great feature for creating an entire curriculum. But a course can only have 1 prerequisite, when you might have expected to be able to assign multiple prerequisites. Since this feature/configuration is so simple the admins end up having to play a greater role in assigning training, because the system can't be configured in a complex fashion. While about 80% of the configuration make sense, the other 20% does not. Some features and configurations are just not intuitive.
Paperless quest
Vorteile:
This software has enabled us to transition away from paper-based serial processes to electronic, parallel processes. It has brought bushiness efficiencies and increased compliance.
Nachteile:
There were so many benefits to our business when we brought in this software. But (understandably) there were growing pains to balance what it/is not configurable vs making changes to long held business processes.
In Betracht gezogene Alternativen: TrackWise und SmartSolve
Gründe für den Wechsel zu MasterControl Quality Excellence: MasterControl's customer service far excelled above the others and the software interface was considered by the evaluation group to be much more intuitive.
A complete eQMS system
Vorteile:
It's relatively easy to setup and use. The MasterControl team really listens.
Nachteile:
It is expensive, but on par with other systems. Still waiting for a validation module.
Qx is beginning to revolutionize our QMS
Vorteile:
Document control, change control, and review workflows are among the biggest challenges facing our organization. MasterControl provides the means to apply industry best-practices, and excellent control and compliance, with intuitive, out-of-the box solutions. MasterControl Qx also integrates with MasterControl's Mx (Manufacturing Execution) system, a critical reason we chose it.
Nachteile:
Onboarding has been challenging. This is not a flaw in MasterControl, but rather a feature: Connections, workflows, training, responsibilities, review cycles ... all have to be specified in detail. We didn't necessarily have all the information arranged in such a way as to make its entry into MasterControl 'easy'. However, once put together, the MasterControl system is far superior to its antecedent.
In Betracht gezogene Alternativen: Greenlight Guru
Gründe für den Wechsel zu MasterControl Quality Excellence: Integration with Mx was a huge factor. We want fewer integration requirements. Also, MasterControl really understands businesses like ours.
With A Quality Eye
Kommentare: It maybe confusing at first but once you understand how all the modules work and how you can adapt it to meet your needs it's great.
Vorteile:
All documentation is in one place and excellent traceability. Electronic signatures reduces paper and time gathering wet signatures.
Nachteile:
The system does require daily administration which needs to be recognised by business owner. The audit module isn't user friendly and could do with some improvements.
In Betracht gezogene Alternativen: TrackWise
Warum MasterControl Quality Excellence gewählt wurde: Needed to be regulatory compliant
Gründe für den Wechsel zu MasterControl Quality Excellence: MasterControl offered a one stop shop with the various modules and reporting process.
MasterControl Works
Kommentare: Overall experience with Qx has been excellent. Implementing most of the quality event forms had been relatively easy and end users have expressed having a good experience using the system.
Vorteile:
I like how easy the software is to use for end users. It is also set up to be easy for admins as well.
Nachteile:
The only con is that some of the features aren’t configurable for admins, so there are a lot of workarounds needed.
In Betracht gezogene Alternativen: Veeva QualityOne EQMS
Gründe für den Wechsel zu MasterControl Quality Excellence: Feedback from other customers who used MC recommend it.
Good System
Vorteile:
- Easy to configure and modify when necessary - Very responsive customer service
Nachteile:
- Process module is not very customizable (When customized, lose MC support if "breaks" during update) - Jump start package created a mess for our documents module
In Betracht gezogene Alternativen: Qualityze Suite
Gründe für den Wechsel zu MasterControl Quality Excellence: Qualityze was newer to the industry at time of selection, MasterControl has years more of experience.
MasterControl - Where Quality Changes Everything
Vorteile:
We have been using the Audit, Process, Documents and Training modules and find the interconnection between the modules to be the most useful functionality that we did not see with our other systems. MasterControl is easy to use and in most cases is intuitive in terms of the workflows and visibility to end users. The MasterControl Support team have been one of the best I've worked with and they will work quickly and effectively to ensure any issues are resolved and applicable feedback given.
Nachteile:
Analytics / Reporting has been one of our main pain points and although there are many reports across the system and modules which show individual elements etc, there are not many reports which contain a full data set of information needed especially in terms of Training or Process reports. We also have some wishes for future enhancements to the software and this is where the MasterControl User Voice forum comes in most handy where users can submit ideas for enhancements as well as vote on other use voices.
Excellent Product and Customer service
Kommentare: The customer service and technical service has been excellent!! I've never worked with a friendlier or more helpful partner. The overall experience with MasterControl has been superb!!
Vorteile:
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.
Nachteile:
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.
Paper to MasterControl user
Kommentare: Excellent, we are going into Mx in 2024
Vorteile:
Ease to use and customize, being able to track progress and audit trail
Nachteile:
It took a bit of time to create the base line for migrating all doc from previous platform
In Betracht gezogene Alternativen: QCBD
Zuvor genutzte Software: Intelex Quality Management Software
Gründe für den Wechsel zu MasterControl Quality Excellence: Capability to keep growing
Promising but needs more
Vorteile:
First and foremost, it has a great user interface. Certain elements like the task list and document explorer are accessible and easy to navigate.
Nachteile:
The workflow builder is quite limited. You either have to rely on MasterControl's prefab workflows or try your hand at building your own (which is quite complicated) and forego MasterControl's support on those forms. There is a new platform for building these forms/workflows, and I am hopeful that it delivers a satisfying product.
Total Quality Management with One System
Kommentare: Interconnecting all apsects of quality management in one system, and allowing them to speak to one another. For example, a CAPA raised from an Internal Audit uses two different modules in the system, but the full traceability of the event remains linked.
Vorteile:
MasterControl is a powerful system capable of total quality management if configured correctly. Each of the modules communicate with one another, making everything in the system fully traceable. MasterControl as a company is always innovating and looking for ways to streamline and improve the system.
Nachteile:
We are on a cloud quarterly upgrade schedule. It would be nice if Cloud customers could opt for yearly upgrade to avoid the pains that come with upgrading a large system every three months.
Broad Quality Management System.
Kommentare: Quality records are easy to maintain.
Vorteile:
Applicable throughout our company. Easy to develop forms as work-flows.
Nachteile:
Training does not allow for open-ended review and comment. Exams are limited to multiple choice, true/false, matching, sequencing or numeric answers only.Users can be added to tasks without having roles assigned by a system administrator.
MC Review
Kommentare: I am the sysadmin and have learned a lot about the system. I think it is a powerful tool once you know how to use it.
Vorteile:
It routes our documents along a workflow and it allows us to manage training in one platform
Nachteile:
If a user hasn’t had a lot of experience with the system, they easily get lost.
In Betracht gezogene Alternativen: TrackWise
Warum MasterControl Quality Excellence gewählt wurde: We could not manage training in our old DMS
Gründe für den Wechsel zu MasterControl Quality Excellence: It’s features and the price
Daily User / Master Control Administrator
Kommentare: I have setup, maintained and used multiple training database systems, this one is very basic and for the most part user friendly. The reports needs to be more user friendly. There are multiple sites within my company that use Master Control and there have been issues with Master Control billing that has let to time wasting activities.
Vorteile:
Master Control is a user friendly, real time data management system.
Nachteile:
There are 2 cons to Master Control (both reports related); running reports is NOT user friendly and report layout is not detailed enough.
Quality Excellence Review
Vorteile:
Like that workflows naturally mirror our quality processes
Nachteile:
Wish action item completion dates would automatically populate in capa
In Betracht gezogene Alternativen: TrackWise
MasterControl Quality Excellence in a heavily regulated industry.
Vorteile:
The ability to have all of our documentation in one place is vital. Especially in case of any regulatory audit.
Nachteile:
Bugs in the system create significant problems for end users. These bugs in some cases also eliminate the ability to use or even in some cases access features or utilities that are being paid for and are supposed to be included in the system. In most cases if the issues being seen are not able to be duplicated, there is no root cause which proves in and of itself to be extremely difficult to document and explain in a heavily regulated industry.
MC Qx review
Kommentare: It always has been a pleasure to work with the system and all Master Control team. Have been using it for years and it was realy good experience.
Vorteile:
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.
Nachteile:
As a global service sometimes it is harder to get a new needed for specific company feature added. But not impossible.
Great Software
Kommentare: Really like the tool
Vorteile:
Easy to use, configurable and scalable. Without needing to do too much customization!
Nachteile:
Some features are limiting and she be configurable by admins (I.e. changing user passwords)
Great quality solution
Vorteile:
Scalability for a global organization with frequent acquisitions
Nachteile:
License per module per user but have since switched to Qx Complete
In Betracht gezogene Alternativen: TrackWise und SmartSolve
Warum MasterControl Quality Excellence gewählt wurde: One system for one company
Gründe für den Wechsel zu MasterControl Quality Excellence: Complete package with eBR and price
Completely Connected
Kommentare: Having training tied to the SOP and linked to the Production Records for real time verification.
Vorteile:
MasterControl has allowed processes and documentation to be connected across the platform. Meaning I can connect a customer complaint to the CAPA and the CAPA to the SOP and the SOP to the training that satisfied the preventive action developed from the complaint.
Nachteile:
Audit Module could use a makeover. Does not function like the newest features. I know it has the possibility of being great.
Review of MasterControl document module and processes module
Kommentare: Very powerful eQMS system and looking forward the AQEM to be implemented
Vorteile:
Being able to create form and design the workflow to reflect the real process is such useful tool and help QA and RA departments a lot in my company. Also great job in the annual upgrade! The updates in each year make the Mastercontrol easier for users to use and be able to do more functions in a better way
Nachteile:
There are too many steps and clicks if linking the document to e form is required
Don't know how we got along without it!
Kommentare: At AcelRx we went from a paper based system to MasterControl and there is no comparison! Definitely made things so much better to keep control of documents.
Vorteile:
Being able to have all our documents in one place is great. Launching DCO packets is so easy. Being able to log into MasterControl from anywhere makes collaboration easy for anyone to do especially since we have been working from home. Also having control of your documents and signature manifests from DCOs help to streamline audits. I also have to say that MasterControl has been the easiest system to help keep all users training up to date and on time.
Nachteile:
with all the updates and upgrades the cons I had have been improved