Michael O. Email & Phone Number

Indianapolis, In, Us

Indianapolis, Indiana Area

The Quality and Risk Management organization is responsible for driving IT Quality and overall maturity by implementing best practice to fulfill business and applicable regulatory needs. This is supported by the Quality and Risk Management Service Catalog and includes:Managing the Risk Management Programo Risk Assessmentso Program Governance (Benchmarking, Scorecard and Reporting)o CAPA ManagementValidationo Base validation of SaaS offeringso Validation Serviceso Validation Maintenanceo Validation Workshops Complianceo Audit Managemento Consortium Managemento Contract Managemento Controlled Document Managemento Self-Inspectiono EducationThought Leadershipo Marketing Plan and Strategyo Industry Summits (internal and external)External Surveillanceo Regulatory & Industry Best Practice Surveillance (e.g. GxP, Privacy, HIPPA, etc.) o Industry Conferenceso Industry Forums and Committees (e.g., GAMP, DIA, CSA, IVT)

The CSV External Benchmarking Forum is an informal association of representativesfrom the Life Sciences industry that meets routinely to discuss current perspectives andtopics related to IT Controls, Computer System Validation (CSV), IT/Automation bestpractice, computer system inspections trends, and current computer system initiatives inthe Life Sciences industry. The purpose of the meetings is to have an exchange ofinformation about the areas above as they relate to IT risk, quality and regulatory (GxP)compliance.This forum also facilitates members conducting benchmarking initiatives to gather datafor their respective companies. This can include ad hoc surveys, questionnaires andforum discussions to gather data on specific subject matter. Results are summarizedand shared with the forum members to be used within their respective companies. Allresults must be approved by the Chair(s) and “sanitized” to remove company specificidentifiers.The forum may partner with other industry forums or special interest groups (e.g.,GAMP, SQA, ASQ, DIA), but will remain an independent entity to ensure that the principles ofthe CSV External Benchmarking Forum remain intact.