IT-Audit-Presentation

RCM TechnologiesIT Auditing for GxP systems and How to Integrate into a Company's IT Continuous Improvement ProgramASQ PRESENTATIONJanuary 15, 2009By Armand MintanciyanRCM Practice Lead, Audits & Quality Management SystemsArmand Mintanciyan• RCM Practice Lead / Audits and Quality Management Systems• 19 Years Validation and IT Compliance experience for pharma, biotech, medical device companies• CISA, CQA, CSQE, PDA TR-32 qualifiedCell – 609.731.9553E-mail – armand.mintanciyan@rcmt.comRCM Technologies• Providing business and technology solutions since 1971• Over 30 locations throughout North America and Puerto Rico (four offices in California)• International development and delivery capabilities• Vertical focus on Life Sciences, Healthcare, Banking & Finance, Insurance, Telecom, Utility, Technology, Manufacturing & Distribution, & Government Sectors• 1,000 national, regional & international clients • Annual revenues approaching $230MM• Three primary divisions: Engineering, IT (Life Sciences) and CommercialIntroduction• Understand why auditing IT vendors is important• Become familiar with the terminology and principles of effective IT auditing and integration into an IT continuous improvement program• Learn how to perform audits based on risk• Determine which audit techniques best suit your needsWhy Audit Vendors of GxP IT Systems• Computerized systems which impact the manufacture, distribution, holding, or testing of drug product, substance ...