Life Sciences/IT Compliance
Mr. Ferrell is a recognized expert in Computer System Validation particularly in the Cloud and Emerging Technologies space. Mr. Ferrell was co-founder of CompliancePath Ltd, a Scottish and US Compliance services company that supports regulated clients all around the world. Mr. Ferrell has held executive and senior level management positions with a number of technology firms in the Life Sciences, including but not limited to RURO, Promedim, CompliancePath, ThermoFisher, QIAGEN, ByteGrid, Sidus BioData.
Mr. Ferrell 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. Mr. Ferrell is a member of the ISPE GAMP Steering committee, Chair’s the Cloud Special Interest Group and was the project lead and main author of the ISPE GAMP IT Infrastructure Control and Compliance Guide published in August of 2018.
Mr. Ferrell is a trusted advisor to the US FDA, having provided CSV, Cloud and Data Integrity training directly to field consumer officers and branch division chiefs. Mr. Ferrell’s relationships with the US FDA led to the ISPE GAMP IT Infrastructure Control and Compliance Guide being endorsed by CBER, CDER and CDRH as well as the MHRA in the UK. Currently Mr. Ferrell is working closely with one of the US FDA Chief Policy Advisors to provide insight to the agency in emerging technologies such as Pharma 4.0, IOT, Machine Learning and Artificial Intelligence.
In May of this year Mr. Ferrell brought together an international group of speakers headlined by the US FDA for a ‘Cloud Compliance’ conference in Washington DC. Mr. Ferrell is currently working with the FDA to showcase emerging technologies in the Life Sciences and on programming a conference on the same in March 2019.
Mr. Ferrell’s industry experience includes managing IT compliance processes to ensure adherence to applicable regulatory statutes (Global GxP, FDA, cFDA, Health Canada, HIPAA/HITECH, FISMA, FedRAMP as well as financial and government regulations) and standards (ISO 9001, SSAE 16, EHNAC, ISO 27001, NIST 800:53, HITRUST, ITAR). The implementation, analysis and risk based testing of traditionally architected and virtualized/cloud based systems in the Pharma, Biotech, Medical device CRO and Health IT verticals. Mr. Ferrell is a Certified Information Systems Auditor (CISA), and is Certified in Risk and Information Systems Control’s (CRISC).
Stephen is a partner in UK and US Compliance Services firm CompliancePath Ltd., is retained as RURO’s Chief Compliance Officer, is a co-owner of Promedim a SaaS based Medical Monitoring solution, and Caledonian Informatics a Life & Health Science contract software developer.