Life Sciences Quality Management System: 5 Must-Have Features & Functionality

The right life sciences quality management system (QMS) can put your organization in a position to get to market quickly, scale fast, breeze through regulatory certifications, and dominate your industry. The wrong QMS can stunt your growth and keep you from doing all of those things.

As a QMS provider, life sciences companies come to us all the time frustrated because they picked a bad solution. They need to migrate to our platform from a system that didn't fit their needs.

That doesn't mean Qualio is the best fit for everyone. (Our solution works wonders for life sciences companies with 5-500 employees.) But, we can show you some essential features that all companies should look for in a quality management system for life sciences.

5 Essential Features of a Life Sciences Quality Management System

The most important function of a life sciences QMS is to support a quality-driven culture. There’s a very clear business case for greater quality at life sciences organizations. Quality products are linked to happy customers, productive employees, and better financial growth. Missing the mark on quality can lead to delayed time to market, costly compliance issues, and expensive product recalls.

Adopting a centralized, cloud-based QMS can give you a huge advantage over competitors, who may still be using paper-based quality systems or disconnected software stacks. Nevertheless, the single-best QMS option for your company can vary, depending on your size, growth stage, and goals.

There are a few critical features that every life sciences company needs in a QMS. Collaboration, automation, and linked processes are some of the non-optional ingredients in a quality-driven culture. To see these features live, click here to schedule a Qualio demo.

1. Real-Time Collaboration

When teams work together using an enterprise communications platform in the cloud, there’s measurable business value. A recent Forrester study found that there's are many practical benefits to adopting real-time collaboration features, including:

• Stronger communication
• Enhanced teamwork
• Higher productivity
• Connected company culture
• More accessible leadership

In addition, real-time collaboration is an essential feature for life sciences QMS systems to support employees' ability to work from any location or device around the globe. Employees can use social features and user-friendly workflows to collaborate around 21 CFR compliant documents, approvals, training, and other common quality processes.

2. Training Management

A cloud-based QMS can integrate training management processes, creating a streamlined improvement over SOPs and training documents that are stored in various cloud drives and paper file cabinets. One immediate benefit of this feature is the opportunity to centralize eLearning content in one single location for more efficiency and lower risks of losing important knowledge.

Learners can access content on-demand to verify SOPs at the point of work in a format that’s convenient for the workspace, such as tablets in a laboratory. Training management provides clear, audit-ready trails of learner activity and engagement with content, allowing more individualized response to learner needs. Finally, training management features can simplify compliance and reduce staff educational costs.

RELATED READING: How Much Does eQMS Software Cost?

3. Automated Workflows

Automated workflows can be replicated across common processes, such as laboratory sign-offs or document approvals, to ensure your company complies with quality standards each and every time. Automated workflows are an essential feature for life sciences QMS systems because they foster the kind of consistent quality activities that prevent error.

Trying to manually manage workflows using paper-based systems, email, or shared cloud drives is a recipe for omission and inefficiency. Automating common quality workflows improves transparency throughout the entire product lifecycle. It helps companies achieve the visibility needed for a culture of continuous improvement and reap the full benefits of a quality management system.

4. Quality Events

Quality events is among the most critical QMS features to comply with life sciences regulations and standards. However, not all quality event feature sets are the same. If this feature isn’t designed correctly, it can lead to a host of issues such as “death by CAPA” or constant firefighting.

A system needs to be able to identify and log quality events that occur at any stage of the product lifecycle. However, it should make it easy for your company to actually get to the root cause of quality events in order to fully resolve issues. The best QMS software will offer intuitive tools to see patterns among recurring quality events and rank issues according to risk.

Ineffective CAPA was the single most common reason life sciences companies received an FDA warning last year. A useful quality events tool can help you avoid the top compliance pitfalls and target meaningful improvements.

5. Processes Linking

A Quality Management System isn’t a series of standalone processes. You should be wary of life sciences QMS which silo your data or make it difficult to link processes. One single document change can have a ripple effect across related processes. QMS features should help you see the big picture and automate all of the activities needed to manage interconnected processes.

Other Considerations

Narrowing your QMS vendor search based on these top five features for the life sciences industry will increase the chances you find the right product. In addition to features and functions, consider fit. A QMS software that hits all of these checkboxes may fit better or worse depending on whether it’s designed for your company’s size and stage.

Qualio is clear about where we fit in the industry. We offer scalable, flexible, and easy-to-use QMS software that’s designed for FDA-regulated startups and scale-ups with 5-500 employees. The fact our QMS is purpose-built for emerging life sciences companies means we offer a fast track to adoption. Being realistic about a vendor’s fit for your size can help you optimize value from your eQMS investment.

To learn more about our QMS, click here.