Hivebench fda compliance software#

Patent on speeding up software compliance Co-authored Computerized Systems in Clinical Research w/ FDA & DIA: Co-authored & prototyped 21 CFR 11 guidance with FDA. Positions include Chief Compliance Officer :, Director of QA and MIS Director. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Perspective / Compliance Notes / ConclusionsĪngela Bazigos is the CEO of Touchstone Technologies Inc.This presentation will provide a baseline of information related to cloud computing which will help the attendee better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system. The potential economic and resource advantages to using cloud based environments guarantees that management will expect that compliance strategies will be developed that will support decisions to utilize cloud environments to perform regulated activities.

This presentation will provide a discussion of Cloud concepts, terminology, definitions, architecture, and services review the contradictions and challenges of using a cloud environment to support regulated activities discuss assessments of cloud hosting facilities and stress the importance of a detailed Service Level Agreement (SLA).Ĭloud computing has become perhaps the hottest compliance topic related to computer validation and electronic records. Cloud computing is a current example of this evolution. Each new wave of technological evolution has been accompanied by a series of compliance challenges, and subsequent strategies to comply with applicable regulatory requirements. The evolution of computerized technologies has been both amazing and challenging.

Hivebench fda compliance