Validation of computerized analytical and networked systems. (©2002)

• Record Type: Book
• Further Information: Note: Ludwig Huber.
• Other Names: Huber, Ludwig, 1948-
• Contents: 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.
• Publisher Details: Englewood, CO : Interpharm Press
• Publication Date: 2002
• Copyright Date: 2002
• Extent: 1 online resource (viii, 228 pages), illustrations
• Subjects: 615/.19/0285; Pharmaceutical technology -- Automation -- Quality control; Pharmaceutical industry -- Data processing -- Quality control; Software Validation; Computer-Aided Design -- standards; Drug Industry -- standards; Laboratories -- standards; Quality Control; MEDICAL -- Drug Guides; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; MEDICAL -- Nursing -- Pharmacology; Electronic books
• Languages: English
• ISBNs: 9781420025910; 1420025910
• Notes: Note: Includes bibliographical references (pages 201-210) and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.