Validation of chromatography data systems : meeting business and regulatory requirements /: meeting business and regulatory requirements. (©2005)

• Record Type: Book
• Further Information: Note: R.D. McDowall.
• Other Names: McDowall, R. D; Royal Society of Chemistry (Great Britain)
• Contents: Introduction to chromatography data systems -- Regulatory requirements for CDS validation -- Concepts of computer validation -- CDS validation : managing system risk -- Process redesign to exploit the tangible benefits of electronic signatures with a CDS -- Writing the user requirements specification -- Controlling the work : the validation plan -- System selection -- Auditing the CDS vendor -- Contract, purchase order and planning the installation -- Risk assessment and requirements traceability -- Installation qualification and operational qualification -- Performance qualification (PQ) or end-user testing -- User training and system documentation -- IT support of the system -- System description -- Validation summary report -- Defining electronic records for a CDS -- Maintaining the validation status during operational life -- Periodic review of the CDS -- Records retention -- CDS data migration -- CDS system retirement -- Retrospective validation.
• Publisher Details: Cambridge : Royal Society of Chemistry
• Publication Date: 2005
• Copyright Date: 2005
• Extent: 1 online resource (xxix, 259 pages), illustrations
• Subjects: 543.8; SCIENCE / Research & Methodology; SCIENCE -- Chemistry -- Analytic; Chemistry; Science; Chromatographic analysis; Computer software -- Validation; Chromatographie -- Logiciels; Logiciels -- Validation; Industrial quality control; Chromatographic analysis; Computer software -- Validation; Chromatographie; Logiciels -- Validation; Electronic books
• Languages: English
• ISBNs: 9781615833726; 1615833722; 9781847552297; 1847552293
• Related ISBNs: 085404969X; 9780854049691
• Notes: Note: Includes bibliographical references 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.