Item: MasterControl Quality Excellence
Rating: 6
Author: Verified User

Overall Satisfaction with MasterControl Quality Excellence

Use Cases and Deployment Scope

We use MasterControl Quality Excellence extensively to meet regulatory requirements for life sciences and medical device manufacturing. The platform enables us to digitize paper records, manage document control, and administer training programs. As a customer for over 20 years, we’ve built thousands of electronic form processes over time. Currently, we maintain 132 active eForm processes, multiple document workflows, and support two business units across nearly 10 locations. While MasterControl Quality Excellence remains central to our operations, we’ve begun transitioning select business processes to other platforms out of operational necessity.

Pros and Cons

Pros

21 CFR Part 11 Compliance
Process module allows customized business process development via standard web dev technology (HTML, JS, CSS)
Provides significant customization capability

Cons

Tech support
Existing product development and integrating user feedback
Software Validation and frequent, sometimes critical defects
Credibility

Return on Investment

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.

Usability

Users consistently report frustrations with MasterControl’s UI/UX. Basic tasks are overly complicated. For example, in my experience, creating a new document revision involves multiple redundant steps with no clear feedback and unnecessary filtering through unrelated documents. I feel that the reporting tools are unstable and unreliable. They outright break. In my experience, we’ve spent dozens of hours annually shutting down services, rebuilding databases, and reconstructing report datasets just to keep them operational. The tool is now inoperable, and in my opinion, MasterControl deflects responsibility to third-party limitations, and blaming our data volume. Despite admitting these issues, in my experience, they offer no resolution other than charging extra for their replacement tool, Insights. We've considered moving to new platforms because of a lack of reporting and support in resolving report issues. A database isn't usable if you can't use the data in it.

Alternatives Considered

Isolocity, Intellect QMS, Veeva Vault Quality and Greenlight Guru

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.

Key Insights

Do you think MasterControl Quality Excellence delivers good value for the price?

Not sure

Are you happy with MasterControl Quality Excellence's feature set?

Did MasterControl Quality Excellence live up to sales and marketing promises?

Did implementation of MasterControl Quality Excellence go as expected?

Would you buy MasterControl Quality Excellence again?

Likelihood to Recommend

I would recommend MasterControl Quality Excellence because it fills a niche space for Medical Device manufacturers and Life science companies. If you're looking for a platform that provides document control and e-Training capabilities, MasterControl Quality Excellence may be a good fit. If your organization has software developers, Process module is also an excellent tool that allows developing a web page inside the system for creating electronic forms. Templates that are developed are configured with an automated workflow, and use of keywords allows seamless part 11 compliance.
With all of this said, if you want a turnkey solution, this is not it. In my experience, MasterControl Quality Excellence is not a user friendly application, and the initial configuration of the system can easily be done in way that isn't scalable, and does not set you up for long term success. In my opinion, there is no out of the box method to resolve this, and poor implementation can lead to poor long term outcomes, and a mountain of tech debt.

Comments

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20 Years of MasterControl Quality Excellence in Life Sciences Strengths Limitations and Lessons Learned