Do I Need an Electronic Quality Management System?

Electronic quality management systems (eQMSs) are powerful tools that connect different types of quality data, enforce workflows, and allow easy access to information within your quality management system, but they can also be expensive. Whether or not you “need” an eQMS depends on many factors.

1.      Are the people at the company co-located?

If everyone works in a single on site location, you can use a paper based QMS. But, if folks are spread out across the country or even across the world, you’ll need a 21 CFR Part 11 compliant method of storing and approving documentation.

2.      Do the people at the company have extensive experience working in the medical device industry and following cGMPs?

If the people at the company are used to operating within a QMS and know what the current requirements are, an electronic paper system (i.e., using electronic signatures and storing documents in a shared electronic location) can work well. Discipline is required to ensure that electronic records are stored in the correct location, editing permissions are limited, and that approved records are not modified or overwritten. Significant quality assurance oversight is required to enforce manual processes.

3.      Are the people at the company good at following written procedures?

If people at the company aren’t good at remembering to follow a written procedure to execute a process, strong QMS controls are required and an electronic paper system is not a good solution. A fully featured eQMS software will force workflows and required reviews and approvals, which can be helpful for those not used to operating within a regulated industry. A fully featured eQMS software can be burdensome to implement, but requires less quality assurance oversight during use.

4.       Are you currently executing all QMS processes?

If you’re still early in the design and development process and aren’t generating nonconformances or complaints, a pared down eQMS software may be a good solution. There are several 21 CFR part 11 compliant software solutions for document control and some fully featured eQMS software offer their software modularly (e.g., you can buy the system 1 module at a time). This can be a great option for companies that eventually want a fully featured eQMS software, but don’t need all the eQMS software features just yet.

Want to discuss whether an eQMS is right for you?

Contact Cooperative Quality Solutions to discuss eQMS software solutions.