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Early EQMS Adoption is Over. Now, Let the Exciting Phase Begin!

EQMS - 23 August 2013

It’s that time of the year again: Our SOLABS QM user group meeting is just around the corner! It’s always a great pleasure to talk to Quality assurance professionals on the use of EQMS in the Life Sciences industry. This year is special because our SOLABS QM 10.0 product is completed and one of the key contributors to its development will be presenting with me: Michael Meighu.

In our presentation, Mike and I will be discussing the automation of quality operations and best practices. Here, there’s a real change in perspective for us. Why? Well, because the industry is currently adopting EQMS more and more, as evidenced in LNS Research’s Quality Management Survey (“27% of companies overall currently evaluating an EQMS solution. EQMS adoption rate is well above the planning stages for ERP and BI, and reflects some of the pain points around quality that companies are trying to address.”[1]).

This means that we contributed to developing this automated practice in the Life Sciences industry. We had to spend a lot of time educating, explaining benefits and often times simply explaining what EQMS is. But this early EQMS adoption period is now over.

Now we are entering an exciting phase, for me personally as well as for all our team. We will stop spending as much energy on explaining what EQMS can do for you, but more interestingly, how to use it to actually improve your level of compliance, plan resources more adequately, provide the right level of visibility to executives, etc.

Here is my angle: We must always remember that EQMS supports the quality operations, but just like a good waiter in a restaurant, you should barely see him, but he’s always there when you need him.

Main ideas we hope to develop with clients during our user group meeting:

No.1 Quality Transactions:

EQMS is all about transactions and sign-offs. Obviously, EQMS records dozens of transactions daily including changes to a user, creating a new document, etc. But when I refer to transactions, I mean sign-offs such as confirming a training, approving a document, initiating a change control, etc.

So … My perspective on quality transactions is: You must aim at being able to forecast the amount of expected quality transactions in the coming month vs. your available resources. If you cannot, you will have to disrupt operations to make up for quality gaps, or you’ll simply become out of control from a quality standpoint.

No. 2 Good IT Practices:

There are good IT practices for maintaining and supporting your EQMS that must be well in place. I believe vendors will take more and more responsibility in supporting clients in this aspect. We will discuss annual reviews of access rights, backup and recovery, disaster recovery, incident management and control of electronic copies.

This year, I am extremely happy to share the discussion with Mike who helped SOLABS grow into the Quality assurance space.

I’m very glad we will have the opportunity to exchange on this subject, for which we share the same passion, although not always the same views…

[1] The Global State of EQMS

Authors: Matthew Littlefield & Mike Roberts

Date: Sep 10, 2013