Paperless verification of non-IT equipment in UCB’s manufacturing with ALM/Quality Center

Video

Abstract

Encouraged by the success of deploying ALM/Quality Center for the global SAP implemen­tation, UCB expanded its use across the IT organization, with ALM/Quality Center lev­eraged for the strict testing requirements for pharmaceutical applications to support clinical development and market authorization, includ­ing mobile apps and web-enabled applications for patient interaction.

However, the manufacturing side of the busi­ness was still run in a traditional, paper-led manner. This changed when the decision was taken to build a new biotechnology manufac­turing plant in Belgium.

The team of Emmanuel Devos (IT Lead Testing Centre of Excellence at UCB) could showcase that ALM/Quality Center could increase the efficiency in the delivery of all audit-related deliverables and facilitate a digital approval process with its electronic signature capability.

With over 14.000 entries logged in the ALM/ Quality Center Requirements module and the estimate of at least 50.000 test executions over the course of the facility’s completion, the increased visibility and end-to-end traceability is already proving very useful.

In close collaboration with Micro Focus R&D and CTG as local implementation partner, the team assessed the current paper-based processes, mapped the pro­cess entities to ALM/Quality Center modules to create mockups and define the level of con­figurations to meet the full requirements.

Emmanuel Devos (UCB) and Wim Demey (CTG) will present you more details about this exciting journey.

About Wim Demey

Solution Architect, CTG

With 24 years of experience in software testing, Wim has gradually developed into a versatile generalist covering various aspects of testing. Driven by versatility and a great curiosity to learn, he is always looking for how and where to stretch his comfort zone to take on new challenges. It enables Wim to operate with a helicopter view as well as to discuss the details.

Besides that, Wim is a regular speaker at international conferences.

 

About Emmanuel Devos

IT Lead Testing Centre of Excellence, UCB
Emmanuel Devos is working at UCB Biopharma, with more than 20 years of experience in pharmaceutical industry and in particular 13 years of experience in IT. Since 2014, Emmanuel leads the IT Testing Center of Excellence in charge of designing and managing functional, performance, automation and medical device testing.

Besides that Emmanuel also sets up eQualification/testing processes for manufacturing non-IT equipments.