The MasterControl Quality Excellence suite bundles a number of products supporting work quality and compliance including training and exams, incidents and corrective actions (CA), documents and change, and other modules.
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Polarion ALM
Score 9.8 out of 10
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Polarion ALM is an application requirement management software platform now owned and supported by Siemens since the 2015 acquisition. It is available on the cloud (Polarion X) and on-premise. Polarion connect teams and projects to improve application development processes with
a single, unified solution for requirements, coding, testing and release.
The MasterControl Quality Excellence suite is well suited for the life sciences and biotechnology as well as manufacturing companies that could benefit from the regulatory compliance that this suite of products offer. This product is highly recommended for industries that want to reduce paper overhead and digitally transform their QMS into a singular location
Polarion ALM shines where it is intended to be used: Application Lifecycle Management. It fits well with agile development concepts, but the extensive customization abilities allow it to adapt to other concepts, too. It is suitable as an all-in-one solution, which is capable of giving transparency over all related areas, be it Requirement Management, Test Management, Release Management, Defect Management, etc., to the involved stakeholders.
Requirement management in Polarion is extremely effective, with a simple but powerful authoring environment, simple approval process management, seamless traceability and advanced reuse capabilities
Test management capabilities allow to link together the requirements with the validation process, and let the user define, plan, execute and record tests across the whole development process
Day bay day management of development is easy to track, with out of the box support for agile methodologies, live planning reports and integration with Git, SVN and CI/CD tools.
There is no trigger if there is a duplicate document in the system. Since each InfoCard has its document number, unless used simultaneously with someone else, there is no trigger for duplicate documents.
When searching and looking at all the documents on the system, it would be nice to have a time column showing when it was released. All I am currently going off of is taking the document number and the highest, but that also takes time.
You can't get rid of a subtype if you have data associated with it. So if you enter documents a certain way and your team decides to change how, things will be more efficient, etc. You can't delete that subtype until you remove all data from the system, even if you don't need some. It's a big task if you have been using it for a long time.
would rate MasterControl Quality Excellence a 7 out of 10 because, while it offers strong compliance tools, centralized document control, and effective audit readiness features, there are still areas that could be improved to enhance the overall user experience. The platform can sometimes feel complex and unintuitive, especially for new users, and customizing workflows to fit specific organizational needs can be challenging. Additionally, integration with other enterprise systems isn't always seamless, which can slow down processes. Despite these drawbacks, the system remains a reliable and valuable tool for maintaining quality and regulatory compliance.
There is too much at stake to go into a new system. But with everything else being promised as far as newer more innovative products, the justification to not renew is a huge risk so that is not a concern
Some tasks require the users and SysAdmin to access multiple modules at a time. For example: to create a training course and an exam for a document in the system, the user needs to finish creating the document in the doc module, then go to the training module to create a course and an exam separately. Ideally, from the document page we should be able to access the training course, which could have some fields auto-populated. And from there, also create and link an exam, all without leaving the document page.
Polarion ALM can be used individually and what I do with Polarion ALM is decided by my configuration. Lesson-learned, operational risk management, product, system or software development or customer management .... doesn't matter at all. I decide with my configuration what I will do with Polarion ALM. Of course, you can also use Polarion ALM out-of-the-box for your development because it comes with a large set of project templates.For this reason, I would also recommend not to just get started. A suitable consultant will show you the right templates and customize them according to your needs. Having Polarion ALM is like having a car. You know exactly how to operate the car. You've done it a thousand times before. The details are in the configuration: did I have a navigation system installed or not? Do I have a lane departure warning system or not? Do I have cruise control or not? Unlike when buying a vehicle, almost all functions are already available and can be used, usually at no extra cost. However, if something is missing, it can be obtained via the manufacturer's extension portal. Individual extensions are subject to a charge. Polarion ALM - easy to deploy and easy to use.
The Technical Support team has grown exponentially over the last couple years. Some front line support staff are new to the system and so know less than the clients do. Back line staff are more seasoned and provide immediate assistance to the front line staff. They have an extensive knowledge bank to assist them as well as client access to most KB articles. Annual user group conference gives us chance to meet the support staff an also to resolve any outstanding issues. Any critical vendor notices are emailed immediately when found and a patch offered at the same time. These are rare, but quickly resolved.
I rated the MasterControl in-person training a 10 because it was clear, practical, and well-paced. The trainer explained concepts thoroughly and answered questions effectively. I appreciated the hands-on walkthroughs, which made it easier to understand how to apply the system in real scenarios. Overall, it was a valuable learning experience that boosted my confidence in using MasterControl.
transparent and immediate when the documents are updated. Easy to check on training and customizable to the company's expectations. Allows easy exam creation with GXP assist and the correlation between job codes and courses has proven reliable. What i would advocate is that you see who has trained on the course in the Course Infocard, to the document infocard
The implementation of MasterControl Quality Excellence was largely successful, earning an 8 out of 10. The project was well-structured, and the implementation team provided solid guidance throughout the process. Key milestones were met on time, and the system was configured to meet most of our core requirements. One of the most valuable aspects was the hands-on training and support during go-live, which helped ensure user adoption. However, there were some challenges around data migration and aligning the system’s capabilities with our existing workflows, which required more time and effort than anticipated. Overall, the experience was positive, and the lessons learned have positioned us well for future system enhancements.
MasterControls' user interface is more visually appealing than others I have seen. It enhances the user experience of utilizing MasterControl Quality Excellence and provides clearer visual cues when certain items require attention. Other systems I have used rely on knowing what will execute the functions without much assistance. MasterControl provides additional cues when hovering over items that require entry to provide additional context.
Some tool suites look cheaper at first, but the hidden costs make it expensive in the end. This also applies to the operation of the application or, in the case of some manufacturers, I would have to speak of stitched applications. Regardless, with all tools it becomes critical at some point. We have found for ourselves that when safety and/or security come into play, things get tricky with most applications. Ultimately, it is and remains a matter of taste and the food should be based on the requirements and not on personal sensitivities. I hope everyone makes the right decision for themselves and the company.
Paper-based change control processes that previously took weeks have been reduced to days, significantly improving operational efficiency and document turnaround times.
Custom-developed forms within MasterControl Quality Excellence have enabled data validation at the point of entry, which has substantially reduced input errors and deviations. This benefit, however, is dependent on internal developer resources, as the platform functions primarily as a host.
After 15 years of use, poor initial implementation and software limitations created lasting technical debt. System migrations to resolve these issues is still ongoing after years of manual efforts, and unmet functionality continues to impact productivity, forcing additional software purchases to address gaps.
The traceability features in Polarion ALM help identify and address issues early in the development cycle
Polarion ALM provides real-time dashboards and reporting, offering stakeholders visibility into project status, progress, and quality metrics.
The initial implementation of Polarion ALM may require time and effort. Some organizations may face challenges in adapting to the tool, and there might be a learning curve for users, especially those new to ALM solutions.