http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Validation and qualification in analytical laboratories
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.
Includes bibliographical references (pages 281-297) and index.