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
• 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