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Pharmaceutical, medical device, med tech, biotech, and cell and gene therapy companies all use MasterControl. We have options for every organization from small start-ups to global businesses.
Small and early-stage pharmaceutical, medical device, or biotechnology companies looking to manage and improve their clinical, quality, and regulatory processes.
The service offered by MasterControl has been excellent and system setup was easy thanks to a very good support. Customer Service team, as they responds quickly and offer good solutions.
Training features are frustrating in the sense that documents are inaccessible to users who have not completed a training task.
Many standard but configurable solutions based on best practices. Great tools for pharmaceutical validation of their solution.
There are company-wide jokes about "Master Control Hell. At least it lets us bond in our commiseration.
I have been a MasterControl admin for over 8 years. From the start, it was apparent that MasterControl is super customer focused and wants their customer to succeed in implementation and beyond.
Requires very skilled and trained employees to execute the daily business processes. Lack of design / GUI customization.
Functionality in MasterControl is great and there are major enhancements on the horizon that will benefit our organization.
We have experienced issues and unfortunately some that have been repeated causing the business to loss confidence in the platform and the control / verification of updates.
The team at Agatha is focused on delivering for their clients. They are responsive and helpful.
The lack of automation in several components, e.g. automatic update of PDF rendition.
The price, ease of use and how intuitive the system is, and most especially how helpful and responsive the customer support is.
We can access any document remotely via the platform and be sure that no information is missing.
The compliance of the software with regulatory requirements is a great advantage.
Sometimes it can be difficult to find the right artefact to implement a specific document. It takes some time to get used to the taxonomy.
They are always responsive and happy to provide help when needed.
Deanna V.: I'm Deanna. I'm a quality system program manager. With the implementation of the MasterControl Quality Excellence tool, I would give it a five out of five. For more reviews like this, please click below. We were a new company that opened up, and we actually had no tools; we only had a paper tool. Prior to us opening up, I actually worked at the same site for a large organization that used another quality tool called TrackWise; however, the TrackWise tool wasn't integrated with other tools such as document control, which was Agile, and training, which was a [inaudible 00:00:37] administration system training. When we went to look for implementation, we wanted one tool where it was all connected, instead of being separate tools. When we went to look for implementation of selecting a software, we looked at multiple companies, and we were really looking for something that was fairly easy to implement and that was integrated between document controls, change controls, training, and other QMS tools we would be implementing. This tool seemed to be the most in line with the regulatory requirements we needed to comply with, and it seemed to be fairly simple in the implementation. During the implementation planning phase, we had to do a lot of cleanup of our own data, so most of our time was spent organizing our master data, and then being able to populate it into the spreadsheets for the upload, so the actual upload was fairly quick. We spent about 12 months cleaning up our data, and we spent about eight weeks from the point of being able to upload our data to completing the entire validation and go live, and we did this between Thanksgiving and Christmas, and it worked out fantastic. One of the recommendations I would have is to make sure your terminology is aligned between what MasterControl gives us for terminology and what you use in your business. For example, the use of deviations; that means something different to different organizations, so take the time to really make sure you understand those concepts and those words they're using so that, when you go to structure your data, it aligns with how they are planning on using that module and using that data. That will save you a great amount of difficulties you may experience after implementation, and we had a few of those because of the terminology issues. Always able to work through them, but we could have been more effective in implementation if we would have made sure we understand the terminology.
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