Short Biography
Ian Francis is an experienced IT Quality, Compliance and Validation professional who has provided advice and support to numerous Life Sciences companies on quality management, IT compliance, validation planning and strategy, compliant business processes, risk management and computer systems implementation with respect to Pharmaceutical Industry regulations.
Ian has an in depth understanding of regulatory requirements and expectations in relation to computer systems and technology, in particular 21 CFR Parts 11, 211 and 820 and corresponding EU regulations for the Pharmaceutical industry (Eudralex).
With over 20 years of experience applying industry best practices and standards such as GAMP, ISO13485 and ISO27000, Ian has also been responsible for managing the development of compliant SDLC methodologies and Quality Management Systems.
Ian has been responsible for the compliance of a wide variety of systems, including;
• Infrastructure (e.g. middleware such as Enterprise Service Bus, network, servers, data centres)
• Quality Management Systems, such as Documentum, HP ALM, ServiceNow
• Enterprise-scale solutions, such as SAP and Oracle E-Business Suite
• Business area specific solutions, such as LIMS, CDS, and eDMS.
• Point solutions such as Excel spreadsheets and SOPs.
Ian was an ISPE Member, contributing to the GAMP Special Interest Group on R&D/Clinical Systems, having authored a White Paper on Data Privacy Compliance.
He is also the co-author of "R: Regulatory Compliance and Validation Issues; A Guidance Document for the Use of R in Regulated Clinical Trial Environments", for the R Foundation.
Ian has spent the last 10 years of his career engaged as a leader in IT Quality, compliance and risk management at Novartis Headquarters (Basel), focused on the Global Drug Development area.