There’s never a bad time to invest in an electronic quality management system (eQMS). As advancements in modern technology allow life sciences companies to continue making staggering breakthroughs, the reality is, organizations that remain tied to manual systems will be left behind.
But here’s the thing, if your company is currently getting organized around its operating budget for next year, it’s an especially good time to allocate resources for an eQMS.
Unlike a few years ago, you have options. Now, life sciences companies of all sizes have access to affordable, easy-to-implement solutions, including eQMS. The days of expensive, enterprise systems reserved only for pharmaceutical giants are over. (Quality leaders who need help presenting an eQMS business case to their executive team should check out this article.)
If benefits like being able to get to market faster and appearing more attractive to clients/suitors aren’t enough to convince you, quality leaders should look for the following five indicators it’s past time to move from a manual quality system to an eQMS:
1. You’ve lost critical documents
Losing a document in a sea of binders and file cabinets, or even behind a desk is a real thing – and it’s awful when it happens. It’s even more of a disaster when you’ve misplaced the actual, final executed copy of a document somewhere in a maze of digital folders. But the worst case scenario is any of this happening while an auditor or inspector is standing next to you, waiting for answers.
And that’s just the current state. What happens when your company starts to scale? It means more docs and records to manually keep track of, more confusion, and more opportunities for things to get lost.
2. Your training matrix is too big for spreadsheets
The training matrix is both a blessing and a curse for life science companies. It's an improvement over pencil and paper, and makes it easier to assign training based on job function or role. A spreadsheet-based matrix also helps ensure that trainees are compliant. However, even a digital training matrix can become an administrative nightmare to maintain and scale. There’s often a breaking point when companies reach more than 20 employees or 50 SOPs. It’s not impossible to handle...it's just harder to stay organized and easier to make mistakes.
3. Your workforce includes multiple locations and/or remote workers
The reality of the post-pandemic workforce is that teams are more likely to collaborate with remote employees and contractors in multiple sites and cities. To stay efficient and compliant in these instances, electronic document signature solutions are a no-brainer compared to scanning, printing, and shipping documents with wet-ink signatures via overnight mail. However, it's critical that regulated companies only use solutions that are fully validated and 21 CFR Part 11/Annex 11 compliant for e-signatures.
4. Your business is being audited frequently
If your business is regularly being audited by your customers and/or the FDA, you know what a drain each one is on resources. Even the best facilities in the world will be judged (sometimes harshly) by an auditor who waits too long for a frantic runner to return from a room full of filing cabinets. It’s not a good look. Put your best foot forward. An eQMS makes it possible to find exactly what the auditor needs in just a few clicks.
5. Your audits result in Major/Critical findings and/or warning letters/483 from the FDA
This one is pretty black and white. If you're getting called out for not demonstrating control of your documents, training program, CAPAs, Change Control, or Audits/Supplier quality programs, your manual system just isn’t working. Please know that an electronic system can help.
The good news is, asking for time to implement a new eQMS in response to any observations is something for which an auditor will definitely make an allowance. So before you race towards the finish line on a thousand other projects, consider shoring up your base with a good electronic system to manage your critical-to-quality activities.
If you recognize some of these warning signs and want to know how you can overcome them, read about how AavantiBio, a Massachusetts-based biotech, found ZenQMS, an affordable, easy-to-use electronic system that allowed them to move away from paper.