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

BySam Clark

chapter 3|28 pages

State-of-the-Art Risk Assessment and Management

ByJohn Andrews

chapter 4|54 pages

Validation Planning and Reporting

ByChris Clark

chapter 5|28 pages

Supplier Audits: Question and Answers

ByGuy Wingate

chapter 6|14 pages

Developing Good Specifications

ByMark Cherry

chapter 7|16 pages

Traceability of Requirements Throughout the Life Cycle

ByKeith Collyer, Jeremy Dick

chapter 8|16 pages

Good Documentation in Practice

ByMichael L. Wyrick

chapter 9|22 pages

Good Testing Practice: Part 1

ByDavid Stokes

chapter 11|32 pages

Calibration in Practice

ByMark Foss

chapter 12|48 pages

Validating Legacy Systems

BySiegfried Schmitt

chapter 13|28 pages

Technology Transfer Keys

ByStewart Green, Paul Warren

chapter 14|22 pages

Qualifying SCADA Systems in Practice Acquisition

ByOrlando Lopez

chapter 16|26 pages

The Validation of a LIMS System — A Case Study

ByDavid Hogg, Fernando Pedeconi

chapter 18|18 pages

Distribution Management Validation in Practice

ByBen Gilkes

chapter 19|16 pages

Good Testing Practice: Part 2

ByDavid Stokes

chapter 20|18 pages

Practical Applications of GAMP Version 4

BySiegfried Schmitt

chapter 21|12 pages

Glossary and Abbreviations

ByOrlando Lopez