PRESENTATION
2002 - User Conference - Monterey
Batch Reporting for Regulated Industries using the Application Framework
Tony and Chris will present a configurable batch reporting application that is targeted at meeting the requirements of federally regulated industries. Specifically addressed is the Pharmaceutical Industry’s need for reporting manufacturing exceptions in a form compliant with FDA 21 CFR Part 11 – Electronic Records and Signatures. The current application uses the PI Module Database, PI SDK and PI ProcessBook automation. Working plans to migrate to the OSIsoft Application Framework will be discussed.
Industry
- Pharmaceuticals & Life Sciences
Company
Infometric Bio Systems
Speaker
Tony Fenn
Tony Fenn was the Director of Automation at Biopure in Cambridge, MA for 9 years prior to representing OSIsoft as an expert in pharmaceutical applications for the last 6 years.
Company
Infometric Bio Systems
Speaker
Chris Nelson
Chris Nelson was responsible for PI System application development and management worldwide for Merck prior to consulting for OSIsoft on the pharmaceutical industry.