Good Computer Validation Practices：Common Sense Implementation

Examining the regulatory and practical issues of computer validation from a global perspective, this text 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 covered 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.