Notes from a Lonely Life Sciences Digital Transformation Junkie (A.K.A Bryan Coddington)

Digital Transformation isn’t about meeting your goals; it’s about blasting through them and reinventing your business. To do that, you often need to throw out the book and find solutions that are new, bold, and even disruptive to your team. As a medical device company, those solutions aren’t just about the latest and greatest technology but ones that also meet the rigor and requirements of the quality organization.

We all know moving to the cloud is a big part of going digital but in Regulated/GxP business areas, such as field service, the qualification of a platform can be a daunting challenge to even the most experienced quality team. But don’t fear the cloud, for it can be as easy as identifying three things - What, Who, and How.

“What” means what are you qualifying? What does the cloud system consist of? Things like configuration, integration, traceability, change control, release management, disaster recovery, user requirements, and IQ/OQ/PQ must all be documented, risk assessed, and tested if needed.

“Who” means who is responsible for the items listed above? A cloud vendor is responsible for their infrastructure, release management, and disaster recovery. As a customer of a cloud platform, you are responsible for documenting and testing your configuration, integrations, user requirements, risk assessment, traceability, IQ/OQ/PQ, and change management.

“How” is about how to accomplish the items you are responsible for. It starts with performing a risk-based qualification effort and then continuing to leverage the supplier’s activity to eliminate the need to re-qualify low risk items. From there, analyze any custom elements and specific configurations against the latest system requirement spec (SRS) and OQ. You then determine gaps and create new scripts (PQ) if needed on top of current SRS and OQ. Finally, you must establish a release upgrade strategy by performing an analysis and testing any issues with step by step guidance.

Now that you know the basics for qualifying a cloud-based field service application, how can it really transform your business? Imagine an application that was built from the ground up to be mobile and collaborative with enterprise analytics and customer/partner communities. But because it’s cloud, you might be thinking that not all areas have Wifi connectivity - and that’s ok. Today’s cloud-based field service applications, like ServiceMax, have offline capabilities so your team can access their data anytime from anywhere. We can go even further with predictive maintenance and IoT, connecting devices out in the field to your application to automatically create alerts and assign technicians.

So how do you be bold and disruptive within your organization to implement a cloud-based field service application? The numbers tell the story. 18% increase in productivity, 13% increase in service revenue, 11% reduction in costs, and 11% increase in customer satisfaction. Management will want this type of change and as you read above, your quality team can sleep at night knowing that cloud platforms like ServiceMax can be qualified.

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