2006 - User Conference - Frankfurt
Demonstrating Compliance: Meeting Reporting Challenges
Regulated industries face additional challenges: meet the requirements of regulating agencies or else—pay stiff fines, be forced to stop production, lose revenues. Striving to meet each new requirement, one-by-one, stretches the budget, yet still falls short of the cost of non-compliance. Companies facing regulatory requirements now must be accountable as well as profitable. The rigors of meeting mandated regulations such as 21 CFR Part 11 and Title V are daunting, and software/solutions vendors are making outrageous claims about “turnkey” systems for meeting them. Today, companies are discovering that approaching each new requirement with a point solution is cost prohibitive and they are seeking a comprehensive, singular solution to what is proving to be a set of problems with very similar characteristics. This presentation will describe why and how OSIsoft’s Real-time Performance Management (RtPM) Platform, combined with RtReports, places your company solidly on the path to systemic compliance and enables you to configure reports that meet the most demanding compliance requirements. RtReports can also be used to generate secure management reports.
Marc Gallant has 15 years of experience working in and with the Pharmaceutical industry, and is currently an OSIsoft Industry Manager and Enterprise Sales Executive. Prior to joining OSIsoft in 1999, he was with Abbott Laboratories in multiple roles, including Manufacturing, Engineering, IT, and Regulatory Compliance. In recent years he has been working closely with OSIsoft’s Life Sciences customers in their Real-time infrastructure planning and has participated in numerous industry seminars and forums, keeping abreast of initiatives such as PAT and 21 CFR Part 11.
Tony Fenn has 20 years of experience in all facets of Quality Assurance and Regulatory Compliance and is currently an OSIsoft Platform Strategist. Prior to joining OSIsoft in 2002, he was the owner and president of a software products company specializing in FDA-compliant batch reporting, and prior to that he was the Director of Automation for Biopure Corporation for nine years. In recent years he has worked closely with many of our customers, both in the U.S. and internationally, to implement compliant reporting systems using RtPM and has trained customers and systems integrators in the application of OSIsoft products.