The regulatory requirements for medical device startups are significant. It’s imperative for your business, not to be ‘killed by paper’ – in some cases even before you get to the market. This is why there has been a surge in the popularity of Electronic Quality Management Systems (eQMS) which offer a number of advantages compared to the traditional paper-based QMS.
Growing document history
Not too long ago, having a quality management system in place meant storing work-related documents on shelves which the staff could refer to as needed. There is little room to adapt to constant change in this system and results in a lack of flexibility for the organization.
Maintaining a paper-based quality management system is quite difficult and time consuming since it takes a lot of effort to find the required data among a growing document history. Running an efficiently functioning medical device company proves to be quite tough in this scenario. Staff members must spend lots of office hours searching through documents for what they need, therefore this outdated system ends up being more of a burden instead of an aid.
Reasons for choosing an eQMS over a paper-based system
These are the 5 main advantages of using an electronic quality management system instead of a paper-based solution:
1. Cost effective – Medical device companies can save substantial amounts of money in the long run by investing in an eQMS. Paper-based QMS’ require hiring and paying more employees to manage all the documentation. When you hire employees, it will take time for them to learn the structure of the current paper-based QMS. In a modern eQMS documents are stored and categorized in a way that makes it easy to locate documents.
2. Less risk – Non-compliance is probably the biggest risk facing your medical device company. Will you be able to find all documents during an ISO audit or FDA inspection? Do you have overall visibility of which documents were signed off and which were not? Is part of your documentation saved on local hard drives or in potentially unsafe locations? All of these risks will be mitigated by switching to a modern eQMS.
3. Time saving – The companies new staff members take less time for training since they can get all necessary assistance and information in a single electronic system. Writing down and manually documenting activities takes up a lot of time which can be saved by using an eQMS – and spent on more productive tasks.
4. More control over documents – Data received from various departments and staff members within the company can be managed, used and updated more efficiently with an electronic quality management system. Employees will have clear guidelines regarding their access to documents.
5. Efficient and motivated employees – The ability to streamline everyday tasks is one of the major advantages of an eQMS. Employees will feel that they have a better overview of outstanding tasks in a digital system. The repetitive tasks of archiving paper, chasing document signatures and making sure all document versions are available in specific binders will be long gone.
The cost of switching
If you think that digitizing your QMS makes sense, the first question that arises will probably be: How much time and effort is needed to make the switch from a paper-based QMS to the eQMS? We have dealt with these questions in the article Medical Device Start-up’s fear migrating to eQMS.
SimplerQMS is a Ready-to-use eQMS for Medical Device Startup’s. We help you take a shortcut to market access by getting the required processes, templates and records in an Electronic Quality Management System accepted by the regulatory authorities. We are 21 CFR Part 11 Compliant and Validated according to GAMP5. This means that you can rely on a QMS and DHF that runs 100% digitally. Get rid of the paper binders, save time and start working more efficiently. www.simplerqms.com