Validation of chromatography data systems : meeting business and regulatory requirements

Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. Validation of Chromatogra...

Full description

Saved in:
Bibliographic Details
Main Author McDowall, R. D.
Corporate Author Royal Society of Chemistry (Great Britain)
Format Electronic eBook
LanguageEnglish
Published Cambridge : Royal Society of Chemistry, ©2005.
SeriesRSC chromatography monographs.
Subjects
Chromatographic analysis.
Computer software > Validation.
Computer programs > Validation.
elektronické knihy
electronic books
Online AccessFull text
ISBN9781615833726
1615833722
9781847552297
1847552293
085404969X
9780854049691
Physical Description1 online resource (xxix, 259 pages) : illustrations

Cover

Table of 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.

Similar Items