MasterControl Quality Excellence is a Quality Management System (QMS) for the life sciences. It enables life-sciences companies to enable flexible quality event management, simplified document management, and automated training management that work together to close the loop on quality.
$25,000
per year
Zelta
Score 8.0 out of 10
N/A
Zelta is a cloud-based unified clinical data management and acquisition platform with customizable modules, that can be tailored to the meet the needs of clinical trials and accelerate outcomes.
N/A
Pricing
MasterControl Quality Excellence
Zelta
Editions & Modules
No answers on this topic
No answers on this topic
Offerings
Pricing Offerings
MasterControl Quality Excellence
Zelta
Free Trial
No
No
Free/Freemium Version
No
No
Premium Consulting/Integration Services
No
Yes
Entry-level Setup Fee
No setup fee
Optional
Additional Details
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Subscription - For larger organizations and those who need a predictable budget. Most modules included without incurring additional fees. Eligible for volume discounts.
Pay per use - For organizations that need flexibility without a long term contractual commitment. Transparent a la carte pricing, no minimums. Fees start when trial goes live.
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
Zelta is a good tool for companies currently utilizing multiple software platforms to create and monitor clinical trial information. Due to the price, it is best suited for large pharmaceutical manufacturers with active pipelines and high R&D spend. Zelta's value is more limited to smaller, more focused companies.
License model can become very expensive for small startup businesses.
More development with validation and more transparent information on how the improvements and or fixes may impact the current configuration. Currently, everything is listed, but it is not tailored to my system.
More information regarding the transition of previous processes to new processes. i.e., FBS to AQEM. I am currently working on the ADV/FBS forms and will eventually transition to AQEM/ADAPT. Still, I would like more information regarding the transition to inform current stakeholders about the improvements on the horizon.
We cannot have multiple study accesses for a study in the studies supported by Zelta. eg. Coder and Data manager.
Though all the study-build related errors are flagged on the study-build page, some errors like incorrect dynamics applied, which eventually affects the subject PDF extraction, reports, etc.
When the study is imported from another Zelta studies, certain attributes remain running in the background even if it seems to be disabled.
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.
We are satisfied from our experience with Zelta by Merative, the close collaboration we have with the Zelta team is also something we value. We plan to use Zelta for a long time
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.
Zelta has many different functionalities as well as modules that can be used depending on what the sponsor wants. I like that they are optional so that when building a study, you can give the sponsor options if they want them or not. Many of the optional models I like to use (Training Tracking for example) as they make tracking Site training so much easier than sending training forms out.
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.
Our organization has been using both Zelta and in-house applications. The main considerations on which one to use for a particular study is time to get the databases running, cost, and ease of use. For some studies, the time and cost of using Zelta are negative factors, and an in-house system is selected.
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.
The products we evaluated were considered as potential replacements for MasterControl Quality Excellence. At this time, we continue using MasterControl Quality Excellence primarily due to the significant volume of data in our system and the operational impact of a platform transition. Intellect QMS emerged as a strong alternative, offering extensive, intuitive business process development tools and a wide range of built-in QMS processes out of the box. MasterControl Quality Excellence currently maintains the advantage solely because of the logistical and business burden associated with migrating to a new system.
It was easier to understand the usability of the software [Zelta]. For our engineers [it] was easier to migrate our data, and fully set up everything. We found out that comparing other software[s], this one is safe, easy to use, has more functionalities, [and it's] easier to work with team members everywhere making clinical trials more efficient.
