IT Outsourcing Presentation by Bob Tollefsen, National Expert Investigator – Computerized Systems to SQA 22-Sep-2011.
{"Image DocumentName": "IT OutsourcingPresentation by Bob Tollefsen, National Expert Investigator \u2013 Computerized Systems to SQA 22-Sep-2011.", "Image ImageDescription": "Emphasized that FDA\u2019s objective is to ensure the integrity of records that are used to support research and marketing permits. Issues with IT and electronic recordkeeping will be enforced through predicate rules. Reviewed several GMP cases where flaws in computerized systems resulted in problems with data integrity and product quality. Expressed concern with outsourcing regulated activities to organizations that traditionally have not operated in a regulated environment. Expressed the expectation for the relationships will be specified in a written agreement and that service providers have a viable quality management system in place. FDA is forming a working group to review FDA\u2019s authority over IT service providers, approaches to monitoring, and topics for guidance (e.g., Cloud Computing)", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}