MARK BRAZIER, MSc
COMPUTER SYSTEM VALIDATION AND COMPLIANCE SPECIALIST
Based in the UK, Mark Brazier has a mix of international business, engineering, and commercial experience in many different cultural environments, providing him with an ability to communicate and perform in many different situations. He has a proven record of success in business development, technical consulting, project and program management, and service delivery. Speaking English and Italian, he has over 20 years’ experience across all areas of the healthcare sector, has spoken at a number of conferences in addition to contributing to international publications.
As a founding partner of Integra, a healthcare project management, compliance and quality consultancy, Mr. Brazier was responsible for day-to-day company operations as well as providing computer system validation services to clients. Services provided to pharmaceutical, medical device, clinical and biotechnology companies included GxP compliance assessments, project/programme management, FDA PAI Quality Assessments (ISO 13485) and remediation, ERP (SAP/JDE) and IS/IT department business process, operations and SDLC definition.
Mr Brazier can help you with:
- Gap analysis of software documentation for US and European device requirements
- Preparation of the necessary software documentation for US and European device requirements, including software verification and validation in accordance with FDA guidelines
- Risk analysis of software-controlled devices
- Review and development of software-related standard operating procedures
- Process validation of software-controlled pharma and device manufacturing equipment
- Quality management system review, development and implementation (pharma and devices)