Journal of Developing Drugs
Open Access

Trustworthy computer systems

5^th International Summit on GMP, GCP & Quality Control

August 12-13, 2016 Toronto, Canada

Orlando Lopez

Indianapolis, USA

Posters & Accepted Abstracts: J Develop Drugs

Abstract :

Data integrity is a global problem and currently a major concern in FDA and European Regulatory Agencies. To ensure the integrity of electronic records, it is essential that the system managing these electronic records must be, at the same time, trustworthy. Trustworthy computer systems are the first line of defense to protect the critical electronic records managed by these systems. The driver of the computer systems validation process is to ensure an acceptable degree of evidence (documented, raw data), confidence (dependability and thorough, rigorous achievement of predetermined specifications), intended use, accuracy, consistency and reliability, or that the computer system is a trustworthy system. This presentation describes the concept of trustworthy computer systems in a GMP regulated activity and, the regulatory requirements and key guidelines associated with the trustworthy of computer systems within the scope of the referenced competent authority.

Biography :

Email: olopez6102@outlook.com