Tag Archives: Quality Solutions

Cyril Walsh, BIOVIA Sr. Solutions Consultant, BIOVIA

Cyril WalshCyril has extensive knowledge on the management of Quality and Regulatory affairs pertaining to automated content management. Cyril has implemented Quality based processes for the management of CAPAs, Deviations, Change Control and Complaint handling. Cyril also has in-depth experience in the services arena having previously worked for Accenture, before beginning his 13 year tenure at QUMAS, now part of BIOVIA, the leader in quality and compliance management solutions for the Life Science industry.

1. What are you looking forward to discussing with the audience?

The focus of our discussion will be defining a true Total Quality strategy and why it’s so critical for Life Science companies. We will give an overview of the challenges of implementing a solution for Total Quality as well as how to overcome them,  the required capabilities for  a Total Quality solution that spans the entire scientific product life cycle from ideation to commercialization and the benefits an organization will experience when implementing a Total Quality strategy.

2. You’ve mentioned that a Total Quality approach includes Quality Process Management, Quality Control and Testing, Materials Quality Management, Quality Document Management and Quality and Process Data Analytics. How would you implement these?

We definitely advise taking a phased approach for the implementation of a Total Quality strategy. Depending on the specific situation and the existing landscape of supporting systems the focus of the first stage can vary. While some of the areas are independent a QMS (Quality Management System) can be a good basis to go forward playing into all stages of the product lifecycle. Usually it is the core of the Total Quality strategy. And as consistent and traceable documentation is basic we recommend considering implementing a centralized integrated system for QMS and Document Management .But we should not forget that metrics are required to validate Quality and in Life Sciences consistent Quality Control procedures and processes are indispensable.

3. Is this topic only relevant for roles that are directly engaged in working with Quality?

Many capabilities play into the successful management and execution of Quality. This includes for example, the definition, documentation, submission, monitoring and management of quality related activities and tasks as well as the execution of quality tests. The BIOVIA approach will support the FDA mandate for deeper integration of Quality into end-to-end operations to design quality into products and processes as well as foster a quality culture across all areas of an organization from discovery to commercialization.

4. What do you hope the audience will learn from this webinar?

By attending this webinar, I hope the audience will which are the relevant aspects and capabilities and the true potential impact of a comprehensive Total Quality Strategy throughout the entire product lifecycle.

Join Cyril in the BIOVIA webinar ‘Bringing Your Total Quality Strategy to the Next Level‘. Register now!