QM APPS: Life Sciences Quality Business Processes
Quality Business Processes - 29 February 2016
What In The World Are SOLABS’ QM APPS?!
It frequently happens when my team and I speak to clients that we hear the following: “What do you mean by QM APPS? I don’t understand–are those modules? What’s the difference between the APPS and the Document and Training Management functionalities? Are these all managed in the same EQMS?”
And then once we explain what the QM APPS are: individual templates for each Quality Management Process, and how they are contained within our SOLABS QM EQMS solution (embedded, integrated, tightly co-joined with Documents and Training), then some people will further say:
“But wait, if you’re selling me an APP, does this mean I have to use the CAPA APP as is? Will one way of working then be imposed on us? Because we like our CAPA process, we’re not looking to change it; we simply want to get rid of our non-efficient and quite scary paper system!”
And then at the other end of the spectrum, it also sometimes happens that clients will say:
“Wait a minute, we’re not looking for a solution that will require months of configuration and process reengineering–just give us a couple of choices of APPS based on industry best practices, and that you feel could a good fit for our company!”
So what we’re doing today is addressing some of the questions, and demystifying some of the elements surrounding the unique model that SOLABS has created for managing certain elements of EQMS like CAPA, Change Control, Complaints, Audits, etc. We make a conscious decision to go with the APPS model as this eases selection of the right process, integration and implementation.
Now: it may be that we don’t always succeed in explaining our unique model in a 5 minute conversation or even in this blog today–and that’s okay too! Because I would love to have a conversation with anyone who wants to know more about our QM APPS!
"QM APPS are Quality Business Processes that SOLABS has built, with extensive R&D investment, using case studies derived from real life and Life Science industry best practices."
Q: What is a QM APP?
A: QM APPS are Quality Business Processes that SOLABS has built, with extensive R&D investment, using case studies derived from real life and Life Science industry best practices. We like to refer to an individual APP as a template that fulfills 80%+ of client requirements, which we can then use to work with clients in building their client-specific process, with very minor to major customization, and everything in between.
Over the years, we’ve built a library of various QM APPS (Quality Events, CAPA & Investigation, Customer Audit Change Control and more), and we grow the library constantly, so that in the next few months, we’ll have enough Process diversity to meet 95%+ of client requirements off-the-shelf.
For example, we currently have three flavors of our Complaint APP. In this context, ‘flavor’ indicates subtle but important differences between versions of the basic Process. One is more geared toward Virtual Pharmaceutical or Contract Organization needs; the second is intended to be used by Medical Device companies, and the third works best for fully-integrated Pharmaceutical and Biotechnology companies.
We have two more Complaint APPS being developed as of now: one will work well for smaller Biotech companies, and the other is a more generic flavor that can be used at Pharmaceutical, Medical Device, Clinical Trial, Virtual, and larger Biotechnology companies.
The take-away I’d like to leave you with today—and take me up on my invite to chat if you’d like—is that SOLABS QM has built in centralized functionalities to manage Training and Document control. Additionally, ALL of the QM APPS work out of the box right away, within the SOLABS universe, and are user-friendly, complete, and flexible.
What our established clients and partners love about this is model is that they have the foundation in place, they train, and they implement the Quality Business Processes as they’re required or circumstances allow. Imagine a very powerful and intuitive base feature set that you could then accessorize with Processes at will—this is exactly what we’ve built!
In a nutshell, that is what our QM APPS are all about!