As operations for life sciences contractors - such as contract research organizations (CROs) and contract manufacturers (CMOs and CDMOs) - scale both geographically and in complexity, an eQMS goes from a “must-have” to a “must-have-now.” From staff training to workflow efficiency to their reputation amongst clients, the right eQMS can make a huge impact on these organizations.
Emphasis on “right.”
To be truly helpful to quality teams and not just another headache-inducing tool, there’s one feature CROs and CMOs in particular need in an eQMS: configurability.
What is configurability?
Configurability is an eQMS’s ability to adapt to an organization’s quality processes, workflows, and regulations without the need for extensive coding. With a configurable system, quality leaders should be able to modify settings, templates, forms, permissions, etc. to better align with their company’s quality and compliance requirements. The best part? Configurability means you don’t have to run to the IT team every time you want to make a change.
Unfortunately, not all eQMS platforms offer configurability, and instead force quality teams into a standard workflow. For life sciences contractors like CROs and CMOs, these rigid, pre-set processes make adapting to client needs unnecessarily difficult. What’s even trickier is that some eQMS platforms say they’re configurable when they really mean they’re customizable. (You can learn more about the difference here.)
More risk, more complexity, more reasons CROs need an eQMS
CROs are taking on more responsibility… and more risk. But as complexity scales, an eQMS can help. Download the eQMS Quick-Start Guide and brush up on how CROs can use an eQMS for smoother audits, better workflows, and risk mitigation across all sites.
Why does configurability matter for CROs?
Configurability is important for quality teams in nearly every life sciences industry, but it’s especially vital for CROs. Here’s why:
- It’s easier to manage multi-site trials. Different trial sites may have different regulatory requirements, operational challenges, training processes, and more, especially if the sites span across multiple countries. In a rigid system, fixed eQMS workflows often cause sites to create manual workarounds which increase the risk of errors. A configurable eQMS makes it possible to tailor the system to meet each site’s needs individually, keeping everyone compliant at all times.
- It keeps teams efficient. Tight timelines and limited resources are the reality many CROs face, and a configurable eQMS means quality teams don’t have to waste time adjusting their tried and true processes to fit the system. Instead, it adapts to the workflows you’ve already streamlined, making it more intuitive to manage your quality needs. This helps teams stay efficient and effective – qualities sponsors prioritize when picking a CRO partner.
- It supports unique sponsor requirements. Each sponsor comes with a different set of expectations, and flexibility is the name of the game for CROs hoping to build strong sponsor relationships. Whether it's specific reporting formats, unique compliance checks, or anything in between, configurability means CROs can meet these demands.
Why does configurability matter for CMOs?
Though CROs and CMOs operations are fundamentally different, their contractor status means configurability still rises to the top of eQMS needs. Here’s how configurability helps CMOs specifically:
- It helps teams meet GMP requirements. A configurable eQMS makes it easier for CMOs to comply with Good Manufacturing Practice (GMP) guidelines. Quality teams are able to tailor the system to fit specific production processes and SOPs, such as those around batch record keeping and deviation reporting.
- It supports scaling operations. With the addition of each new manufacturing site, quality needs inevitably change. A configurable eQMS can scale alongside the business, adapting to fit new teams, varying facility requirements, or increased regulatory scrutiny without requiring a complete overhaul of the system. In short, configurability means quality never lags behind growth.
- It adapts to global regulations. CMOs that operate in multiple international markets have to juggle different regional and global regulations. This can be stressful for quality teams – but a configurable eQMS helps. It allows quality leaders to customize workflows, documentation, and reporting to meet the specific compliance standards of each country. When CMOs enter new markets, configurability can help expedite the process by making sure all regulatory bases are covered from the start.
One final pro tip: Make sure the eQMS you pick makes configuration easy so you don’t have to run to Support or IT for every change. The simpler it is to configure, the easier it is for quality to keep pace with growth.
Curious how configurability can impact your own organization? Talk to our team and see firsthand how to configure your processes in the ZenQMS platform.