Why not use MasterControl as your Med Tech eQMS?

MasterControl is an eQMS system that supports the quality management of complex and highly regulated life science products around the world. Their platform helps organisations control documents, build compliance submissions, manage audits, and orchestrate quality training. Their software is designed to streamline the development, manufacture and ongoing compliance of life-science products in various regulatory regimes. 

What is MasterControl and who is it built for?

MasterControl is a trusted, global provider of quality management software (QMS) to the life science industry. Headquartered in Salt Lake City, Utah, the company now operates across five countries, serving a diverse range of clients from the United States to Singapore.

Their software is used by more than 1,000 organisations worldwide, including major players in pharmaceuticals, biotechnology, and medical device development who all rely on MasterControl to help them de-risk and accelerate their route to market.

The MasterControl system enables large-scale collaboration between teams spread across multiple locations, a crucial feature for global enterprises working on long-term projects.

The pros and cons of MasterControl

MasterControl - the strengths

Training -  a world-beating Learning Management System (LMS)

MasterControl's training module is extremely impressive, helping you link every job role with required training materials. It gives complete oversight of training requirements, while tracking and flagging gaps in individual’s certifications that could cause compliance issues later on. 

Robust SOPs for life-science compliance

Robust SOP templates for NCRs, CAPAs, calibration reporting, change and deviation management can all be tracked and controlled through the system in line with global pharma regulations and ISO standards. They are linked with the LMS (Learning Management System), so changes in process will automatically trigger re-training for workers.

Role-Based Workflows for business and compliance continuity

MasterControl's role-based system allows businesses to set up approval and training sequences against job roles rather than specific individuals. This ensures when people move jobs, the business doesn’t have to swap out email addresses in multiple workflows and risk gaps emerging in compliance process.

Document batch approval

MasterControl allows you to group multiple documents into a single "packet," enabling batch approvals and signatures.  This simplifies common workflows like Design Change Orders (DCOs) by requiring fewer individual sign-offs.

MasterControl - the weaknesses

MasterControl offers a modular system where companies can purchase and implement different functionalities based on their needs. Each module handles a specific aspect of quality management, regulatory compliance, or process control.  

In theory, this means businesses should only pay for what they need, but in reality it can mean complex implementations that never seem to end.

MasterControl can be hard to ‘right size’ for SMEs

MasterControl was primarily designed for larger pharmaceutical companies to impose the rigid quality processes required for drug development across large organisations. But for smaller, medical device companies who want to take a Lean approach to quality management, it’s hard to right-size the MasterControl system to fit their more agile way of working.

Customers report lengthy Implementations

Some SMEs complain that implementation of just one module can take several months, as they struggle to reconcile their existing SOPs with the rigid mechanics of the MasterControl system.  One company worked with MasterControl consultants for around six months to set up their system, but even after this, not all the modules they had purchased were fully implemented. 

Customers complain about inflexible SOP templates

MasterControl’s system is ideal for organisations without established processes, or those who need to implement strict drug development quality assurance. However, the inflexibility of the canned SOPS (such as their CAPA processes) makes it difficult to tailor the system to individual organisational needs. 

As one Capterra reviewer puts it:

“The workflow builder is quite limited. You either have to rely on MasterControl's prefab workflows or try your hand at building your own.  This is quite complicated and means foregoing MasterControl's support on those forms”

Patchy customer support

For smaller businesses, support can be slow and patchy, especially when complex issues arise. Some SME clients from less prestigious brands, complain support from their Customer Success Managers is slow to access.  Many find it’s a long and expensive process to secure extra help for more bespoke implementations. 

Validation packs may raise concerns

MasterControl’s reliance on vendor-supplied validation packs - where they define user requirements and conduct validation - raises concerns about objectivity. Many companies feel uneasy trusting a third party to determine their compliance capabilities, especially as they remain accountable for meeting regulatory standards​.

Only limited customer trials available 

MasterControl often provides only limited demonstrations or very short trial access to prospects typically for just a few days.  This doesn’t give organisations much time to test the system thoroughly. Mostly, users are dependent on demos.  But these can be very misleading as the work required to get started. MasterControl’s sales representatives showcase a polished version of the software, with all functions pre-configured and optimised.

The Cost Factor

Like other eQMS platforms, there are different tiers of eQMS package, from basic to bespoke, enterprise versions.  But MasterControl can be expensive with annual costs ranging from $40K to $60K, not including substantial fees for specific implementation support.

Conclusion

There is no doubt that MasterControl is a powerful eQMS platform, but for many SMEs its complexity and cost far outweigh its utility.  

Smaller, medical device companies need more adaptable systems that can scale alongside their growth. With rigid, one-size-fits-all SOPs and hard to access customer support, systems like MasterControl make a Lean approach to document management difficult to achieve.