As a start-up, you probably face challenges of how to apply all regulatory rules and standards that are required from your company and product and how to implement them into an electronic system.

eQMS gives you a framework for identifying, evaluating, managing and monitoring risk.

First, an individual from the team should be assigned as the person responsible to face and build regulatory strategy (a.k.a. the quality manager). The strategy should be built-up according to the documentation of all procedures and activities right from the project‘s start – if possible.

Although this is the best way, it is not the only way. The reason you want to start as early as possible is that more than in a regulatory environment, half of the product development is about the right documentation. So, implementation of an electronic QMS from the earliest stages is less work.

Because of a limited budget, companies often vary between different software and web application looking for the cheapest and most effective solutions or they simply continue to work paper-based. Delay of QMS implementation and bouncing between the solutions cause risks to non-compliance and can be costly because the solution is usually a consultant billing for a lot of fixing time (consultants are good and are highly recommended, but use them wisely – they can be toxic to budgets).

The right eQMS should fit both the company and the innovations' needs – it should also be affordable. What does affordable mean? For a start, electronic forms are pretty easy, they can be assigned, approved, and pulled through your processes to satisfy all standard and regulatory requirements without running around in the office for signatures and approvals – most importantly they keep their history. Also, to set up your QMS in a short time, don’t forget to train your employees first. Lastly, a comprehensive eQMS solution does not have to cost tens of thousands of dollars for each feature and user – money better spent on a good consultant for product development.

An often overlooked need for an eQMS is audit readiness! Do not underestimate that pending nightmare! Being audit ready, using a paper-based system is close to mission impossible – not to mention overheated printers. There is always “that” one document or “that” one approval signature missing. If you choose an eQMS that includes an integrated document management system (DMS) module, you are halfway to a successful audit… and nothing shuts an auditor up faster, than click, click, click… document history, history in the project, history of tasks leading to this document, history in approvals… click, click, click… including showing its current status in a given process… Ah, the silence that follows! If it’s their first time, I often have to tell them to remember to shut their open silent mouths… as gasping in public is a bit rude… (yeah, smug satisfaction…).

Although it is possible to use Microsoft Office or Google docs for document management, then why use an eQSM DMS? What is the difference?

The difference is significant! A regular document management software (DMS) won’t flow through quality events or through your project tasks in compliance with the standards and regulations require. A good eQMS software should make your compliance easy by driving your everyday work and your projects with quality events included. True, documents are stored in a management system, but they are created through quality processes and flow through the various project task and approval events. An eQMS with an integrated DMS not only keeps track of all this but also keeps a full history. This will be critical later when you create your Traceability Matrix (we’ll get to that one in a future chat soon enough).

I’ve highlighted some features of a fully integrated and automated eQMS and a good integrated DMS. The benefits greatly outweigh the risks if you do it right and start with the right eQMS software.

Nor does it have to be expensive. The eQMS should help you reduce your compliance risks starting during the development phase right through to market launch and beyond. eQMS can help you create proof that the product you developed is safe and effective – and the proof is what FDA and CE Mark require for clearance!

What is your experience? Are you still using a paper-based system or have you already worked in eQMS software? What are your expectations from QMS software? I would really like to read about your experiences, maybe we can learn from each other.