Key takeaways:
In the world of quality management, 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 FDA inspector arrives, the only thing that matters is proof. Unfortunately, massive spreadsheets, or worse, stacks of paper files, make finding that proof difficult. That’s where an electronic quality management system (eQMS) comes in.
An eQMS, or electronic quality management system, is like the digital headquarters for all of your quality management activities. An eQMS is a software platform that allows things like your standard operating procedures, work instructions, training documents, quality records, and more to all live together in one secure, easy-to-navigate digital space.
An eQMS usually contains a variety of modules designed to handle specific quality management tasks. These modules often include things like:
What's the difference between manual quality management, "digital" quality management, and an eQMS? Often, manual quality management relies at least in part on physical paper. Picture stacks of folders, filing cabinets, 3-ring binders, and driving from building to building to collect ink signatures. This process is the most labor-intensive, prone to human error, challenging to audit, and at risk for data loss and non-compliance.
Spreadsheet-based QMS processes, like those that use Excel, can be considered a “digital” option, but still quite limited. Though it’s a step in the digital transformation direction, as the company grows and quality management gets more complex, spreadsheets become impossibly tough to manage. Plus, they lack the automation that’s helpful for audit trails, version control, and real-time collaboration, which means efficiency and compliance still take a hit. Though this type of quality management happens with digital tools, we'd still give it the "manual QMS" label.
On the opposite end of the scale, an eQMS is specifically designed for quality management. It integrates with other digital tools, is scalable, and is built with regulatory compliance in mind.
Quality management in life sciences is a big deal—for obvious reasons. These GMP, GCP, and other GxP-regulated companies deal with products and processes that impact human health, from medicines to medical devices. There's no room for error when it comes to safety. Quality management is the foundation of consumer safety, and it keeps companies moving forward without fear of regulatory disruptions or a lapse in consumer trust.
The problem is that many quality teams are asked to carry out their tasks without the right tools to do so. Unfortunately, manual quality management (think pen and paper, or lengthy spreadsheets) often leads to more errors, missing documents, and wasted time.
But when QA is at its best, business is better. With a tool like an eQMS, quality teams can stay efficient and spend fewer company resources staying compliant and completing successful audits. Plus, the faster they can ensure quality, the faster the business can hit the market. Simply put, companies that prioritize quality gain a competitive edge in an industry where trust is key.
Imagine you need to update a company-wide SOP. If you’re working under a manual quality management system, this means tracking down the authorized approver to give them the paper copy, waiting for their signature (and sending several reminders), and then collecting the piece of paper back again. Repeat for every signature needed. Then, you need to retire the old version, removing all outdated copies from circulation and replacing them with the new SOP.
After manually logging the updates and approvals in your paper file or spreadsheet, you have to share the updated SOP with all relevant employees, and then manually assign and track their training sessions, updating each employees’ training dossier in the process.
That’s a lot of time, effort, and room for error ... all for just one SOP!
If you’re a quality professional, you don’t have to imagine this scenario. You live it every day.
When the weight of the company’s compliance lies on your shoulders, you deserve better tools to do your job. That’s where QMS software comes in. Here’s how an eQMS makes a difference:
For quality management professionals in the life sciences space, an eQMS isn't just another tool. It's an essential ally that these teams deserve, both to make their lives easier and consumers safer.
eQMS stands for electronic Quality Management System.
All GxP-regulated companies can benefit from an eQMS. This is especially true for organizations within the life sciences industry, including:
Though every organization's quality needs are different, regulatory compliance features, scalability, flexibility, and ease-of-use are key factors to prioritize during your eQMS search.
To get in-depth tips on how to choose the right eQMS, how much to budget for the system you need, and how to get your C-suite on board, download the eQMS 101 eBook resource for Quality Management leaders.