<p>This sensible text on computer systems validation examines the regulatory and practical issues of computer validation from a global perspective and provides a common-sense approach to getting the job done. Combining the insights of an internationally respected group of computer systems specialists, healthcare industry professionals, and a regulator, it provides SOPs, checklists, and tips to make global computer validation an obtainable goal. Topics and concerns detailed in the text span the breadth of issues and influences imposed upon computer validation by worldwide GCP, GLP, and GMP requirements and provide an approach that meets the regulatory and real-world needs of the healthcare manufacturing and research industries.</p>

Good Computer Validation Practices: Common Sense Implementation

Science & Math

Stokes, Teri

Branning, Ronald C.

Chapman, Kenneth G.

Hambloch, Heinrich

Trill, Anthony J.

Mathematics

Interpharm Press

<p>Computer validation regulations have increased worldwide by 300 percent since 1991. Drawing on her practical project experience in pharmaceutical, biotech, and software companies around the world, author Terri Stokes provides you with the tools they need to develop validation practices that fit into their organization's culture and can be integrated into the normal workflow of regulated activities. She clearly explains the influences placed upon computer validation by the worldwide GLP and GMP regulations and then helps to integrate good validation techniques into the laboratory or manufacturing environment.</p>

The Survive and Thrive Guide to Computer Validation

Computers & Technology

Programming

CRC-Press

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