Our approach
We deliver projects in line with current regulations and our clients’ own policies. We are results focused and work with clients to deliver on time, whatever the size of the project.
We use a scientific, risk-based approach to validation strategy and apply quality risk management to solve technical problems as they arise. As members of ISPE, we keep up with developments in technology, good practice and regulation.
Our goal is to make sure our clients’ facilities, equipment and processes are fit for purpose.
Our team
Laura Butchart – Director
I have 18 years’ experience in validation, starting as a validation microbiologist in 2008. I hold a BSc in Medical and Environmental Microbiology and an MSc in Pharmaceutical Validation Technology.
I set risk-based qualification strategies for facilities, cleanrooms, utilities, equipment and GxP computerised systems across the full lifecycle, from user requirements through commissioning and qualification to routine operation and periodic review. Since 2020 I have designed, authored and approved CQV strategies for CAPEX and technology transfer projects, and I have led CQV departments of up to 20 people.
My microbiology background led me into sterilisation. I have delivered C&Q in Annex 1 sterile manufacturing, including a vaccine fill-finish facility, cleanroom qualification and environmental monitoring programme design. I have worked with start-ups and established companies across pharmaceuticals, biologics, gene therapy and medical devices.
I have taken part in FDA, MHRA, Chinese NMPA and Russian regulatory inspections and represented clients in many customer audits. I am a certified Kneat Gx power user and lead the development of ValerieCQV.
Wayne Oultram – Director
I have held various roles within the pharmaceutical sector with over 20 years’ experience. I have a wide range of experience which includes formulation development, process development, facility and equipment validation. As well as a broad knowledge of equipment validation in the pharma / bio pharma industries, I specialise in steriliser validation and cleanroom qualification.
As a founding director of ParagonV I maintain a hands-on role in the delivery of validation strategies in accordance with current regulatory requirements.