bokomslag Good Computer Validation Practices

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336 sidor
1994

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.

Författare: Teri Stokes, Ronald C Branning, Kenneth G Chapman, Heinrich Hambloch, Anthony J Trill
Format: Inbunden
ISBN: 9780935184556
Språk: Engelska
Antal sidor: 336
Utgivningsdatum: 1994-05-01
Förlag: CRC Press Inc