A Global Leader in IT Governance & software assurance
CompliancePath is a global leader in US & EU GxP, HIPAA, HITECH, GDPR and NHS directive solutions.
We were founded in 2008 and have continued to develop our global presence in the Life Science market opening our European Head Office in 2011.
In 2018 we opened our nearshore Computer Validation & Software Quality Assurance Test Centre in Glasgow Scotland
TEST CENTRE & VIRTUAL DELIVERY
CompliancePath has been providing remote delivery for Validation and Audit projects for 5+ years. As much as our team is available for on-site delivery if projects require, we now deliver circa 95% projects from our validation test centre of excellence in Glasgow, Scotland.
CompliancePath supports a host of international companies and we continue to be encouraged by the level of support afforded to us by the Life Science community in the US and Europe. Our significant experience in the North American market has enabled us to bring a wealth of knowledge and pragmatism to the UK and EU IT/Software compliance space
Our customers benefit from world class Scottish Universities specializing in Engineering, Computing and the Sciences while being able to offer our customers transparent and cost-efficient labour rates with low attrition penetration.
OUR LEADERSHIP TEAM
Stephen is a recognized expert in regulatory compliance in the Pharmaceutical, Medical Device and Biotech space. Stephen is a co-founder of Promedim & CompliancePath Ltd, a Scottish and US Compliance services company that support regulated clients all around the world. He has held executive and senior level management positions with a number of technology firms in the Life Sciences.
Stephen has implemented Quality Management Systems at several companies at both the corporate and divisional level and has hosted and conducted countless audits across the GxP disciplines, ISO13485 (inclusive of IEC62304/ISO14971), ISO27001, SOC 1 & 2, EHNAC and FEDRAMP.
Stephen represents the Scottish Life Sciences Association in the USA and was a signatory on the historic ‘Turnpike agreement’ which created collaborative channels for US & Scottish Life Sciences companies to share knowledge and expertise. He is a member of the ISPE GAMP Steering committee and was the project lead for the ISPE GAMP IT Infrastructure Control and Compliance Guide published in August of 2018.
Hugh oversees the company’s sales and growth strategy. He is trained in US & EU IT Regulatory requirements and has led pilot projects for key IT systems within the regulated space.
He has significant experience in Product and IT Design Control Validation, Data Centre qualification, Product and IT Quality Strategies, System Implementation, Computer System Validation, commercialisation of Software as a Service applications all for the Life Science and Health IT Industries inclusive of HIPAA and GDPR compliance.
Hugh has led high growth start-ups in both the US and EU and has extensive experience in strategic planning and partnerships to help develop and resource customer solutions.
Hugh holds a Bachelor of Science Honours degree in Technology and Business from the University of Strathclyde in Glasgow.