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Validation of computerized analytical and networked systems

✍ Scribed by Ludwig Huber

Publisher
Interpharm Press
Year
2002
Tongue
English
Leaves
244
Category
Library
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✦ Table of Contents


Content: Regulations and standards --
Terminology --
Design qualification --
Vendor assessment --
Validation during development --
Installation qualification --
Operational qualification --
Maintenance and ongoing performance qualification --
Validation of macros and spreadsheet programs --
Validation of networked systems --
Compliance with electronic records and signatures (21 cfr part 11) --
Operational compliance of legacy systems --
Audits.

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