If reporting corrective and preventative actions in your medical device manufacturing company starts with sharpening a pencil and grabbing a paper form, then you’re about to get left behind as your competitors leap ahead.
Today’s regulations and quality processes are much more strict than they used to be. You have to be able to quickly access information and build reports — otherwise, you risk drastic slowdowns, potential audit failures, and falling behind in your status as a leading-edge company.
If you want to compete, you simply do not have time to sift through stacks of pages, carefully tabulating data as you go, only to find another sheet buried on Bob’s desk just as you’re in the home stretch.
Technology makes corrective and preventative action (CAPA) tracking easy and fast, but how do you choose the right one for your company and your needs? Let’s look at some of the top features that the best corrective action database software providers are including in their tools in 2019 and how those will impact your day-to-day data management.
Attributes and Features of the Best Corrective Action Database Software
Traditionally, when you needed to record a CAPA event, you would fill out a paper form and carefully file it away in the appropriate binder (unless you’re Bob and hide it on the stacks on your desk.)
With corrective action database software, you still fill out a form, and you still choose where to have the software file it away. Your CAPA event recording process really isn’t that much different except for making sure things actually get filed. The real difference comes in your ability to access that data later.
A software program can read and transform that data into useful and actionable information much faster than a human sifting through papers can. Leading life sciences companies understand that this shift is essential for growth and view the right software platform as an asset. They understand that the following features are critical to success and quality management in their devices.
Your Software Must Be User-Friendly
Like most tools — software or physical tools — your employees simply will not use it if it’s too hard to learn or too hard to use.
Many of the top vendors in the Quality Management Software space understand this and go to extraordinary measures to ensure that their software is intuitive and saves time.
If your CAPA software is a pain to use, your employees won't use it much, or they won’t use it well. However, if they love it, you'll get a far better outcome and much tighter compliance with your company processes.
As your company grows, your software needs will too. The top platforms understand that your needs will evolve beyond just needing a place to store CAPA-related assets.
You will eventually need a tool that helps you throughout your entire product lifecycle — from early-stage ideas to interacting with active users of your devices. Today’s software vendors are continually innovating their products to add more tools and resources, streamline processes, and integrate with more of your other systems.
For example, at Qualio, we built the first web-based Quality Management System (QMS) because we knew that growing life sciences companies couldn’t bring life-changing devices to market if they were buried under paperwork. We knew that quality was driven by more than compliance management and complicated systems and that good software helps companies grow instead of holding them back.
RELATED READING: The 8 Essential Functions Of CAPA Management Software
Bringing a complicated and life-altering medical device to life is a big process full of multiple steps, tons of documents, lots of communication, and a whole lot of red tape.
It can be easy to forget to do things as you’re rushing to get to market.
Quality CAPA software will help remind you by using automated reminders to make sure you’re aware of everything that needs to do be done, every action you need to take, and every follow-up that you need to make.
Tracking and Reports
Any corrective action software that you choose needs to deliver powerful reporting — after all, that’s the primary reason to leave paper trails behind.
Corrective action database software will help you achieve true end-to-end traceability across your product lifecycle. You can see links between records, close the loop on your process, and enjoy near-instant access to your data, all of your data, when you need it.
You won’t have to worry about building a manual paper-based report and realizing too late that you didn’t have all the information because someone forgot to put a page in the binder.
You Can Do More by Upgrading to a QMS Software
Using software to manage and track your corrective and preventive actions is just the tip of the iceberg when it comes to medical device manufacturing. When you upgrade to the best QMS software, you can go from a series of disconnected software and paper combinations to a fully-integrated all-in-one efficient platform.
Qualio’s QMS platform is made specifically for growing life sciences companies to help them scale while retaining the quality of their medical devices.
45 Minutes Could Transform Your Business
Request a demo of our software today and discover the potential for yourself. We will walk you through a custom demo tailored to your needs.
- Learn about our approach to quality and how it will impact your company’s future.
- We’ll show you how you can streamline critical quality functions to save time.
- You’ll see how Qualio can help you track and prevent quality issues that could cost you time and resources.
- Learn how to close the loop on your quality management and be in a state of 24/7/365 audit readiness.
In less than an hour, you can discover how to transform your business and outpace your competitors while delivering higher-quality devices to your customers and keeping your employees happy. What do you have to lose? Book your demo today.