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SOLABS Quality Business Processes- Audits, CAPA, Change Control, Investigations

QM APPS Development: CAPA, Investigation, Quality Events, Audits & Change Control

Quality Business Processes - 11 May 2016

By Diem Le, QM APPS Lead Developer, SOLABS

As part of our monthly SOLABS technology blog series, we’re speaking with our software engineers on their reflections on the industry, its development and rapid changes, and how their area of current focus may be pertinent to compliance/regulatory and the future of Enterprise Quality Management System (EQMS) software.

For the first instalment of this two-part interview, we’re talking with SOLABS QM APPS Lead Developer Diem Le, whose current work finds her collaborating closely with a Development team engineering QM APPS, the powerful, lean and intuitive automated business Processes that can be operated on their own, out of the box or customized—but that can also be closely integrated with SOLABS QM centralized Training and controlled Documents sections.

Dan Harbridge [DH]: You’ve been at SOLABS for a long time now! Do you have any stories from your first year at SOLABS that you’d like to share with us?

Diem Le [DL]: Yes, I guess I’ve been at SOLABS for more than 10 years now! Obviously something is going right! Hmm: stories from my early days at SOLABS? I felt a little dumb about this at the time, but I think it’s cute now. Philippe and Phong, who both interviewed me, first took me for a tour of the office, did a demo of the product and an overview of the company for me–and after the tour, I asked them why they needed me at all, since the software was already up and running, and was fully functional!

Maybe I was used to working from the ground up or launching software, but I was probably concerned that I wouldn’t have anything to do if they hired me. The fact is that the SOLABS software that I saw more than 10 years ago was still in its early days, compared to the current SOLABS QM, version 10.4.

DH: SOLABS QM APPS are such a crucial part of our diverse software offering. What, besides your intimate knowledge of the SOLABS QM software, made you the right choice to take on the role of QM APPS Lead Software Engineer/Developer?

DL: The main reason I was chosen to lead development on SOLABS’ integrated business Processes, or QM APPS (CAPA, Investigation, Quality Events, Audits, Change Control, etc.), is that back in SOLABS QM 2.8, I was one of the few people working exclusively on QM APPS.

Fast forward to 2016 with SOLABS QM 10.4, and I’m part of a team of skilled developers. We’ve slowly but surely developed an inventory that covers a wide range of customers’ needs—most common needs as a matter of fact, with variations or ‘flavors’. The success of the software speaks for itself: we’re constantly adding to the QM APPS inventory. And we are always planning more, looking forward.

"We also found out that some people piggybacked [QM APPS], or had two running in parallel, or had ones triggering others—as well as using them in more subtle, complex and multi-layered ways. We began calling these modified versions ‘flavors’, and that is how we began to develop more of them..."

Diem Le
QM APPS Lead Developer, SOLABS

DH: Okay, so QM APPS are like powerful extensions or plug-ins for SOLABS QM—that’s why we call them ‘APPS’, right? QM APPS are individual business Processes that work custom or out of the box, but they are also fully integrated, correct?

DL: With the experience that we’ve accumulated developing QM APPS, we defined a core group of QM APPS that would meet fundamental customer needs. A lot of these are standardized, like CAPA, Investigation, Quality Events, Audits, Change Control, etc., and while comprising the base APPS, are still configurable.

While we were happy with the core group of APPS, we then found that even many of these ‘standard APPS’ required tweaks for each customer. We also found out that some people piggybacked them, or had two running in parallel, or had ones triggering others—as well as using them in more subtle, complex and multi-layered ways. We began calling these modified versions ‘flavors’, and that is how we began to develop more of them, by keeping that flexibility and adaptability in mind.

In some cases, we have to remove certain fields from a QM APP to accommodate workflows, or for compliance/regulatory purposes. In other cases we may have to add fields, to match existing real world workflows–audits, for example. The flow of the core QM APP stays more or less the same in most of the cases—one step extra, one fewer, one more approval, etc. But we’ve been willing, able and more than happy to make every modification we’ve been asked to make so far!

DH: Is there anything that is unexpectedly fun about your job? Is there anything that might surprise people about what you do?

DL: I find that our job is intellectually fun: fun in and of itself, because we’re constantly searching for a better way of doing things: we never rest, we always optimize. The fact that programming is actually a great deal of fun might surprise some people, but I think that anyone who does the New York Times crossword puzzle on Sundays, or Sudoku in the morning newspaper, or anyone who likes looking for hidden connections and concealed logic would find the kind of programming I do very enjoyable!

DH: You have a group of people that work closely with you. Do you enjoy the coordinating and overseeing of various people working, focusing and concentrating their efforts towards a common goal?

DL: I love what I do every day—I am unbelievably lucky! I enjoy helping them when they come to me seeking advice, or they want me to review their code. This whole give and take is super intellectually stimulating and makes everyone better at their job! I also enjoy when they challenge my solutions: if someone can come up with a better, more streamlined or more error-free way of doing the same thing, I am always open to that.

We learn from each other in context all day every day: it’s never boring. It keeps me fresh and young [laughs]; my co-workers keep me smiling, and always keep me guessing! It’s a real pleasure to come to work with this crew every morning!

Read Part 2 of our interview with Diem about SOLABS QM’s Business Process Engine

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