provalidus was formed in May 2005 by Jon Davey.  Since the start, the team has grown to include John Foley, Hannah Booth and associate Bill McCarthy.

Jon Davey Profile.  With over twenty years experience in industry Jon has had a number of roles ranging from Project Engineer, through to more recent roles of Validation Manager and Quality Assurance Manager for a major medical device and pharmaceutical company.

Being a member of the Process Control Special Interest Group (SIG) of the GAMP forum, Jon played and active role in the generation of section 9 of GAMP 4 and the VPCS Validation of Process Control Systems guide.  With nearly ten years assisting group and third party companies improve their validation systems and successfully pass regulatory inspections, Jon realised there was an opportunity to bring his knowledge and experience to a wider audience.  Knowing how to implement systems that are workable for differing organisations is the key to success.  This is only achieved when people genuinely understand and appreciate the subject.

John Foley Profile.  With a background in Instrumentation and Controls Engineering, John has over 20 years experience managing projects to implement and improve process control systems and to develop process control software, in a variety of industrial settings both on- and off-shore.  For the last ten years he has worked as a process controls consultant within GxP-regulated companies, running and executing various validation projects including process control systems and computer systems for building management, maintenance management and product distribution.   John also has extensive experience reviewing documents and sites for overall compliance to validation and ERES requirements, implementing remediation plans and validating existing equipment and processes. 

John joined Provalidus in May-2006 and has specialised in the validation of instrumentation, controls and computer systems.

Dr Hannah Booth BSc, PhD, MRSC Profile - Hannah graduated in 1993 with a BSc Hons in Chemistry and Colour Chemistry, and a PhD in analytical Chemistry in 1997, both from Leeds University.  Since 1996, Hannah has spent the majority of her career at Smith & Nephew Medical Ltd in Hull, where she moved from technical roles, leading and executing product-related projects, into Quality Assurance where she performed a variety of quality systems and operations roles.  As Validation and Change Control manager, she was responsible for all validation, change control, QMS documentation and records on the Hull manufacturing site, including related systems of work, databases and training, and their compliance to GxP regulations. Hannah has provided specialist input to a number of improvement projects, most notably requirements definition for a global quality management system, and implementation of SAP Document Management System on the Hull site.

 Since joining Provalidus in January 2007, the majority of Hannah’s work has been computer systems validation and helping customers develop quality management system processes and procedures. 

Hannah is a Member of the Royal Society of Chemistry and is a trained Lead Auditor (ISO9001:2000).

Bill McCarthy BSc.C.Biol, M.I.Biol Profile - A graduate of Newcastle University, Bill’s background is in Microbiology.  He has a broad range of expertise, gained in more than 30 years working for major pharmaceutical, medical device and consumer healthcare manufacturers.  During his career he has performed a variety of roles, from Company Microbiologist, to QA Manager of an 80-strong department, to Global Regulatory Compliance Manager, providing direction and expert compliance advice to Group sites and 3rd parties, mainly in Europe and the US.  Bill has very extensive managerial, audit and consultancy experience covering all aspects of regulatory compliance for medical devices and pharmaceuticals.   

Bill has most recently concentrated on quality systems support for medical devices and consumer healthcare, advising companies across the globe.   

Bill is a Chartered Biologist, a Lead Auditor and a Notified Body Auditor.

This is where provalidus can help your organisation improve their systems through a programme of training, coaching and mentoring.  Alternatively you can utilise our expertise to deliver a complete validation solution.

What's in a name? Provalidus is Latin with 

pro : (+ abl.) in front of, before / on behalf of, for.

validus : strong, robust, able .