Life science quality management system: 5 must-have features
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. A suboptimal and weak QMS can stunt your growth and keep you from doing all of those things.
As an eQMS provider, life sciences companies come to us all the time because their current quality management system isn't up to scratch.
So whether you're looking to implement a digital quality system or not, we know what works and what should be present in a modern quality management system for life sciences.
5 essential features of a life sciences quality management system
The most important function in a QMS for life sciences is to enable 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 cloud-based eQMS 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 its QMS, whether its on paper, spreadsheets or in the cloud. Collaboration, strong training, and interlinked processes are some of the non-optional ingredients for a quality-driven culture.
Let's take a look.
1. Real-time collaboration
A Forrester study found many practical benefits to adopting real-time collaboration features in the workplac, 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.
Ensure your employees are connected - whether with an eQMS, or with communication tools like Zoom and Slack.
2. Training
Your QMS should integrate training management processes to ensure staff follow the processes you want them to - in the way you want them to.
IDC's whitepaper, 'Counting the Cost of Employee Misunderstanding', found that 89% of life science companies have experienced unplanned downtime from suboptimal training and employee misunderstanding. 85% of those businesses saw reputational damage as a result, while over a third lost business.
Ideally, learners should be able to access live QMS content on-demand to verify SOPs at the point of work. This should be in a format that’s convenient and appropriate for the workspace, such as tablets in a laboratory.
Training management should also provide clear, audit-ready trails of learner activity and engagement with content, to prove to regulators your staff are competent, confident and - most importantly of all - compliant.
RELATED READING: Top 5 electronic quality management systems
3. Standardized workflows
Keep things simple, and ensure your QMS for life sciences encourages employees to do the same things in the same way wherever possible.
Workflows should 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 digital workflows are a hugely helpful feature for life sciences QMS systems, providing consistency and compliant traceability together.
Trying to manually manage workflows using paper-based systems, email, or shared cloud drives is a recipe for omission and inefficiency.
Automating your quality workflows improves transparency throughout the entire product lifecycle - helping your company achieve the visibility needed for a culture of continuous improvement and to reap the full benefits of a quality management system.
4. Quality event management
Quality events are among the most critical QMS ingredients you'll need 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.
Quality management for life sciences products means you need to be able to identify and log quality events that occur at any stage of the product lifecycle. However, you should also consider how to make it as easy as possible 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. Strong quality event processes will help you avoid the top compliance pitfalls and get meaningful improvements in place.
FURTHER READING: Total quality management (TQM): definition and principles
5. Process linking
The modern quality management system for life sciences should never be a series of standalone processes.
One single document change can have a ripple effect across related processes, and your QMS should be geared in a way that provides you that visibility. Be on your guard against siloed processes, like process documents that don't reflect operational realities, or a quality management system that's only interacted with by a handful of quality personnel.
Your life sciences QMS should touch all corners of your business and be supported and nurtured by everyone.
FURTHER READING: How to develop and implement a quality management system
Quality management for life sciences: other considerations
With these requirements in mind, your life science business may find that it's a logical and natural step to digitize and optimize your quality management system for life sciences with dedicated QMS software.
You wouldn't be alone - our 2024 quality trends report found 20% of surveyed businesses plan to adopt an eQMS in the next year.
Narrowing your eQMS vendor search based on these top five quality management must-haves will increase the chances you find the right product. In addition to features and functions, consider fit. 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's QMS software 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.
