When asked when it was ideal to take the eQMS plunge most attendees of our Navigating eQMS Today with Enzyme webinar answered “from the start.” When asked what their top priorities were for evaluating eQMS platforms, attendees were split between wanting “customization” and that it include a “compliant quality system.”
Webinar attendees were also asked what they needed in order to ensure a successful implementation and most attendees agreed the key requirement was “cross department buy-in” or “educational support.”
Following are specific questions attendees asked Jared Seehafer, CEO and Co-founder of Enzyme:
Question: How would you advise a small company with an established paper system to move to an electronic Quality Management System (eQMS)?
Jared: I would ask first: What is the motivation internally, i.e., what’s driving you to migrate now and where are the stumbling blocks, if any, that have stopped you in the past from moving to an electronic system? An understanding of what you expect to get out of the move and why you haven’t done it to date will help align everyone to the goals and expected outcomes of the migration. Because companies with established paper systems can often have a hurdle of inertia when migrating, as you are evaluating, I would make sure that the most “tech phobic” is involved in the evaluation process and make sure that person gives input. Lastly, I would not consider doing the migration in stages. Instead of starting from paper to an eQMS (where records are stored as data, not documents), you should consider an “e-Paper” system, with electronic doc control and training as a milestone before moving to a full eQMS.
Question: What are the biggest challenges with an eQMS implementation?
Jared: Lack of buy-in, team availability, and data availability. We find that there is a critical period of 1-2 quarters (depending on company size), wherein it is critical to ensure the team is onboarded properly, lest the implementation be stuck in a kind of limbo.
Question: Do you have any solutions internally for test case management? What is the mechanism for end-to-end traceability from the requirement through the test case?
Jared: We have written custom integrations for anything that syncs with Jira. So, Zephyr, X-ray, etc. Additionally, we also support other systems via our Application Programming Interface (API). We provide end-to-end traceability and the ability to check if the trace matrix is complete on demand.
Question: Is Enzyme a good fit for an extremely low-risk software-only product company, a SAMD?
Jared: If you have a need to be under eQMS, i.e., you are not under enforcement discretion or otherwise excluded from the definition of a “medical device”, yes.
Question: What function should medical device companies –with a finished product with design tools but nothing on the side of quality procedures– start with their QMS process?
Jared: Start the sequence of first adopting procedures, then aligning to those procedures. You will likely want to start with SOPs on the topic of Suppliers, then on to the post-market side, Complaints, NC, CAPA, etc.