Validation and qualification in analytical laboratories. (©2007)

• Record Type: Book
• Further Information: Note: Ludwig Huber.
• Other Names: Huber, Ludwig, 1948-
• Contents: Introduction -- Regulations, standards, and guidelines -- Terminology and validation overview -- Risk-based validation and qualification -- Master and project planning for equipment and computer systems -- Design qualification -- Installation qualification -- Operational qualification -- Performance qualification and maintenance -- Special considerations for software and computer systems -- Validation of analytical methods -- Data review and validation and evaluation of uncertainty -- Handling out-of-specification situations -- (Certified) reference standards -- People -- Proficiency testing for external laboratory qualification -- Audits.
• Edition: 2nd ed
• Publisher Details: New York : Informa Healthcare
• Publication Date: 2007
• Copyright Date: 2007
• Extent: 1 online resource (v, 303 pages), illustrations
• Subjects: 543.068/5; Chemistry, Analytic -- Quality control; Chemical laboratories -- Standards; Chemistry, Pharmaceutical -- standards; Chemistry Techniques, Analytical -- standards; Drug Industry -- standards; Laboratories -- standards; Quality Control; SCIENCE -- Chemistry -- Analytic; Chemical laboratories -- Standards; Chemistry, Analytic -- Quality control; Electronic books
• Languages: English
• ISBNs: 9780849382680; 0849382688
• Related ISBNs: 9780849382673; 084938267X
• Notes: Note: Includes bibliographical references (pages 281-297) 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.