Ludwig Huber

Validation of Computerized Analytical Systems (eBook, ePUB)

• Format: ePub

Produktbeschreibung

Covering the entire validation process, from writing a validation plan through implementation, testing, and installation qualification, to ongoing calibration, performance qualification, and change control, this book provides readers with complete validation details. It discusses international and FDA regulations with numerous practical examples th

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 268
• Erscheinungstermin: 28. April 2023
• Englisch
• ISBN-13: 9781000948226
• Artikelnr.: 67850443

Autorenporträt

Huber, Ludwig

Inhaltsangabe

Chapters include: 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 Qualification
of Networks Compliance with Electronic Records and Signatures (21 CFR Part
11) Operational Compliance of Legacy Systems Audits Appendices include:
Glossary and Standard Operating Procedures