Stands for good clinical practice is an international set of quality regulations and guidelines for design, conduct, monitoring, recording, auditing, analysis, and reporting of studies applicable to the clinical or human studies in the evaluation of drugs, medical devices, biological product, etc… FDA ensures quality product applicable to GCP via 21 CFR Part 50, 54 & 56.
Published in Chapter:
A Practical Approach to Computerized System Validation
Kashif Hussain (University of Valenciennes et Hainaut de Cambrésis, France)
Copyright: © 2009
|Pages: 14
DOI: 10.4018/978-1-60566-002-8.ch032
Abstract
This chapter provides a practical approach to computerized system validation (CSV) for the pharmaceutical organizations for the users dealing with the validation. Validation package including plan, responsibilities, and documentation needed and created during the validation are also discussed. Any computer system can be validated utilizing the techniques described here. These activities address the organization commitment to implement the underlying system in order to improve, ensure and maintain the quality standards. The CSV is described as a reference and an orientation guide to understand the related quality processes. The activities presented here should be useful for initiating and conducting the principal tasks of validation. This chapter reflects a quick guide and addresses one of the “non-technical” aspects of CSV methodology. A clear approach is presented that defines the CSV activities and provides an efficient means of validation to new and existing systems, applications, and environments within the organization.