Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions.

This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.

chapter Chapter 1|4 pages


chapter Chapter 2|9 pages

What Is a Computer Systems Validation (CSV)?

chapter Chapter 4|4 pages

Maxims * in CSV

chapter Chapter 5|8 pages

General CSV Principles *

chapter Chapter 6|6 pages

System Life Cycle

chapter Chapter 7|8 pages

SLC Documentation

chapter Chapter 8|18 pages

Management of the Computer System Requirements *

chapter Chapter 9|10 pages

Risk Based Validation

chapter Chapter 10|6 pages

CSV Plans and Schedules *

chapter Chapter 11|6 pages

Project Management, SLC, Production CSV, ITIL

chapter Chapter 12|8 pages

Computer Systems Operational Life *

chapter Chapter 13|6 pages

Suppliers and Service Providers *

chapter Chapter 14|18 pages

Trustworthy Computer Systems *

chapter Chapter 15|6 pages

Control of Data and Records

chapter Chapter 16|22 pages

Technologies Supporting Integrity of E-Records *

chapter Chapter 17|8 pages

Infrastructure Qualification Overview

chapter Chapter 18|10 pages

Remediation Projects

chapter Chapter 19|8 pages

Production CSV Program Organization

chapter Chapter 21|6 pages

Digital Date and Time Stamps

chapter Chapter 22|16 pages

New Technologies and Critical Processes

chapter Chapter 23|6 pages

All Together