gamp 5 guidelines for computer system validation pdf

Thus, the risks of “human error” are no longer constant, while increasing the productivity and efficiency of processes does not depend on people performing repetitive tasks or require a high level of effort, leaving human hands to control tasks and maintenance of these systems, which provides room for creativity and process improvement.

The computerized systems that have an impact on product quality, patient health, and good practices (GxP, as in the case of those who serve production processes, storage of inputs and finished products, insurance quality, documentation management, electronic records, etc.) must be validated, in order to meet normatively, ensure the integrity and traceability of information and product quality.Ĭomputer systems with GxP impact are becoming of particular importance today due to technological advances in process automation and data management and information generated by applications, and the increasing acceptance and use of these technologies in both administrative industrial, and productive processes.Īs computer systems are increasingly integrated into many of the most important business processes, they help to reduce or eliminate the risks inherent in manual processes traditionally performed by qualified personnel. Through the principles and methodologies suggested here, this guide will help the organization to ensure that computer systems prove their fitness for intended use, meet the good practices of the industry in an efficient manner, provide practical guidance to facilitate the interpretation of regulatory requirements, with a language and terminology easy to understand and interpret, clarify the roles and responsibilities of each of those involved in the validation of computerized systems.įinally, this guide is designed for understanding the principles of validation of computerized systems by the most diverse personnel, both those who occupy this knowledge as part of their daily work and those who at some point will be involved in the effort to validate a system without any prior knowledge of Good Practices, validation or IT computer terminology, thus becomes a valuable tool for both and for anyone who wants to train others in basic and logical principles of work on Computer Systems Validation.Ĭurrently, the Health Industries such as pharmaceuticals (human and veterinary), pharmochemical, (APIs and excipients), biologics, biotechnology, blood products, and medical devices, are required to establish a validation program to demonstrate that any procedure, process, equipment, material, activity or system actually leads to the expected results.

Gamp 5 guidelines for computer system validation pdf