When it comes to GxP regulation, if it wasn’t documented, it didn’t happen … and that’s a problem for the quality teams who pour countless hours into keeping their companies compliant. When the auditor arrives, the only thing that matters is proof.

Unfortunately, massive spreadsheets and stacks of paper files that take time to sift through make finding that proof difficult. While manual quality management tools might “get the job done,” quality teams – and the critical organizations they support – deserve better, more effective tools. The thing that surprises most people is how quickly organizations actually outgrow manual solutions (more on that below).

What Is An eQMS?

An eQMS (electronic quality management system) is a quality management software platform that functions as your single source of truth for all of your GxP quality activities. It not only houses your signed SOPs, it proves that you approved those SOPs per your defined workflow process, that you reviewed those SOPs in a timely manner and that all trainees completed training ahead of your effective date. It replaces training binders and excel sheets with an intuitive system for reporting on training status across many levels, including document, trainee, job function/role, training course etc. But it also allows you to define and enforce your quality process for managing critical quality events (think CAPAs, change controls, management quarterly review, signature requests, etc.) in a secure, automated system. This is not ‘paper on glass’…it’s a validated workflow engine purpose built to assist your team in documenting your GxP activities.

An eQMS usually contains a variety of modules designed to handle specific quality management tasks. These modules can often include:

• Document Control: Manages document versions, approvals, and distribution.
• Training Management: Assigns and tracks employee training automatically and ensures compliance with regulatory requirements.
• Issues and Change Controls: Allows reporting and tracking of CAPAs, deviations, complaints, general issues, change controls and other form/process-driven activities.
• Audit Management: Facilitates management of a vendor list and audit/qualifications schedule, as well as planning, execution, and follow-up of internal/inbound audits and outbound vendor qualification activities.
• Insights/Reporting: These systems include a great deal of actionable intelligence – and the good systems make getting to this valuable data a simple task.

Why Should Life Sciences Companies Migrate Away From Manual Quality Management?

Quality management for GxP-regulated organizations is a big deal. It’s the foundation of consumer safety, and it keeps companies moving forward without fear of regulatory disruptions or a lapse in consumer trust.

Unfortunately, quality teams are often asked to carry out their tasks without the right tools to do so. Although manual quality management systems are a fine place to begin, they lack features that can deliver a great deal of value such as validated electronic signatures. For organizations with mature quality systems, maintaining them with manual and homegrown tools makes it harder to ensure compliance requirements.

With the right eQMS in place, quality teams can not only more effectively help their organizations stay compliant, they can actually have an impact on future business success. From its ability to support the Quality team to its direct effect on revenue, here’s how an eQMS outshines manual quality management:

• More efficient, more compliant, more good days: An eQMS automates many quality management functions like requesting signatures, version-controlling documents, and tracking training. That means less time spent chasing down colleagues for signatures or logging changes in dozens of different places. Instead, Quality teams can spend more time on projects that help drive continuous improvement across the organization.
• Quality data is power: Few teams have access to more GxP critical data than the Quality department. From deviation trends to efficiency reports, Quality teams get an inside look at what’s working and what’s not. A robust eQMS with solid data tracking can help them provide leadership with actionable insights on where to invest more resources and where potential problems may arise before they impact operations.
• Audit readiness: Not only does an eQMS make it easy to track your quality documents and processes, it also allows you to find exactly what you need when auditors show up. Instead of scrambling to meet an auditor’s request, the right evidence is at your fingertips every time in a locked down, audit trailed platform, making sure your organization gets credit for its commitment to quality.
• A centralized hub connecting remote staff and supporting remote audits: Your team might be spread across different cities, countries, or even continents. An eQMS makes it easy to manage and approve quality activity like document revisions and training from anywhere. More importantly, your team can host auditors from anywhere or even make reference documents available on demand, limiting need for some onsite audit activity.
• An investment in trust: Companies that prioritize quality gain a competitive edge in an industry where trust is key. Investing in quality sends a message to potential clients, Sponsors, and partners that you’re not only following best practices and safety standards, but you can prove it. And for Life Sciences investors conducting due diligence, an organization that uses an eQMS shows its low tolerance for risk, appetite for standards, and ultimately, its long-term stability, making it a more attractive asset.

Must-have eQMS Features For Life Sciences Organizations

Your QMS software wish list will ultimately depend on your organization’s size, structure, and operations. But whether you’re prioritizing training, CAPA management, or something in between, every regulated company should add these features to their eQMS must-haves list:

A Pricing Structure That Doesn’t Inhibit Growth

Many quality management software platforms price by seat, meaning however many people will need access to the system is how many user licenses you’ll need to buy. Even worse, we see complicated licensing structures by access rights or modules that require a PhD to understand. With this pricing model, every time you add a new person to the team, you’re stuck either running to your CFO for more budget or playing a game of musical seat licenses to figure out who gets booted from the system. Or worse, you resort to sharing login information (for the love of 21 CFR Part 11, please don’t do this!). A QMS with an “e” in front should be for the enterprise and it should be affordable for the entire organization as it scales. 

But it doesn’t have to be this way. Some platforms offer one all-inclusive price regardless of how many people will access the system. When choosing your eQMS, scrutinize the pricing structure. Ask yourself, is it cost effective now? Will it still be in a year if I double in size? Does the pricing model punish growth? Can anyone be a document author? If seat licenses won’t work for your team, don’t hesitate to find an alternative.

Barrier-free Access To Validation Materials

Software validation isn’t optional for cGMP, cGCP, and other GxP-regulated companies, which means a simple validation process should be on your eQMS must-have list.

Some eQMS platforms charge for validation materials and/or support, and some don’t. For those that do, you’ll either have to pay to leverage their validation documentation or commit to handling it yourself from scratch. Remember, you’ll likely run into these fees again when it’s time to revalidate the system after a major software update (and all SaaS platforms require updates 1-4x per year) so this process should be easy.

Alternatively, you can shop around for a quality management tool that provides free, simple-to-use validation materials. Bonus points if they provide no-charge, speedy support from start to finish. More bonus points if they offer qualification checklists or templates.

A User Interface Your Organization Will Actually … Use

It’s not enough for your eQMS to be easy for the quality team to use; the general once-a-month user has to be able to figure it out too. If every time they need to complete a training or sign off on an SOP they end up spending ages just trying to navigate the system, you can bet they’ll start to push off their quality assignments.

And you don’t want to spend most of your time chasing down employees to remind them to stay compliant or retraining your colleagues on how to use the eQMS every time they log in.

Ease-of-use should be a top priority when vetting a new eQMS. When evaluating a new platform, ask for a sandbox account you can use to test the system so you can get a first-hand look at just how simple to use it really is.

A System That Flexes to Fit You

Finding the right eQMS can feel like a guessing game. Too many features and you’re bogged down in a complicated system; too few and your eQMS becomes outdated as you grow. Plus, a system that’s too rigid and templated means you’re forced to adjust your quality workflows to match your quality software’s title conventions, document categories, signature requirements, etc.

When you’re on the hunt for an eQMS, make flexibility a priority. The system should be highly configurable, meaning it allows you to adjust forms and stages to match your current processes, adapt your workflows, define custom fields and meta data, and more. The key? It should be easy to configure without requiring intervention from an IT consultant or the software’s development team and without an extra customization fee attached. In short, it should do exactly what you need today and adapt to your tomorrow.

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About the Author
Panos Boudouvas is Co-founder and CEO of ZenQMS, whose mission is to elevate the role of quality in the Life Sciences and support quality professionals with the digital tools they need to succeed. Find him on LinkedIn.

Download the eBook eQMS 101: The Fundamentals of Quality for insights about how to: choose the right eQMS, budget for the system you need, and get your C-suite on board.