ABSTRACT

All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements and provides guidance from seasoned practitioners

chapter 2|16 pages

An Inspector’s Viewpoint

chapter 4|54 pages

Validation Planning and Reporting

chapter 6|14 pages

Developing Good Specifications

chapter 8|16 pages

Good Documentation in Practice

chapter 9|22 pages

Good Testing Practice: Part 1

chapter 11|32 pages

Calibration in Practice

chapter 12|48 pages

Validating Legacy Systems

chapter 13|28 pages

Technology Transfer Keys

chapter 19|16 pages

Good Testing Practice: Part 2

chapter 21|12 pages

Glossary and Abbreviations