Enterprise Quality Management Solution
Quality is without question an intrinsic part of the Life Sciences DNA. We all know that quality can’t be taken for granted and doesn’t come free. Of all the investments that need to be done as a mid-market Life Sciences organization, implementing a quality management solution is one where there is no debate about the need. That doesn’t make the choice an easy no-brainer.
An Enterprise Quality Management Solution (EQMS) can be a point solution or integrated by nature with your EDMS. Where point solutions provide a strong focus on the key quality processes like audits, deviations and CAPAs, these solutions lack the ability to deliver an integrated end-to-end solution.
Quality should tie in with your EDMS. Evidence as part of quality events must be kept under control of the EDMS and even progress, without impact to the evidence. Also, documentation impact of events – e.g. the need to update an SOP and run the TBR training for it – are part of the end-to-end regulatory records for that event. Therefore, EQMS Express is delivered as ‘just’ another module on top of the OpenText Life Science Suite, the industry solution that delivers industry best practice and the implementation of the DIA EDMS and eTMF reference models out-of-the-box.
EQMS Express thus is a Quality Management module built in Documentum D2. While it’s built to work along the Documentum Life Science Suite, it can also be installed as a standalone application.
You may wonder: Why “Express”? Why not just EQMS? That is because of our focus on the mid-market and industry start-ups. While there are reputable solutions that also are great tools for Quality Management, their target audience is mainly the larger companies. We have learned that their offer is too much from a feature perspective and too much from a TCO perspective for most mid-market companies. This is where EQMS Express comes in. It has all the bells and whistles a Quality Management Solution should have, but its main target is mid-market.
Although its focus is mid-market, that doesn’t mean you have to look for another QMS once your company has outgrown mid-market. Just like the Documentum Life Science Suite, EQMS is built in D2 with the thought of adding to the Documentum LSS with a Quality Management module. Knowing Documentum LSS is a favorite with pharmaceutical companies, so much so that 19 out of the top 20 drug makers use one or more of its solutions, you know it’s capable of handling the demands of large companies.
Out of the box, you got your CAPAs, Deviations, Audits, … etc. If your business has processes/events that aren’t provided along EQMS, it’s still possible to add this to the solution. If EQMS comes with events you don’t need, it’s just a matter of disabling that event.
If there is need for customization, agile projects go hand in hand since it’s build in Documentum D2. Most customization can be done by configuring, which means, with the right training, you can have your own people maintaining your solution.
EQMS is a nice addition to the Documentum Life Science Suite. Both can be provided by DOLSR, a cloud platform for life science/bio tech. Documentum LSS and EQMS also work well together with SPA4LS, a SharePoint add-in if you’re in need of sharing documents with an external partner in a controlled environment.