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Publication Source: ISPE Baseline® Guide, Vol. 6: Biopharmaceutical Manufacturing Facilities
Publication Date: 2004
See also: Parameter Monitoring
Reviewing a clinical study, ensuring conduct, proper records and reports are performed as stated in the clinical protocol, standard operating procedures, Good Clinical Practice and by regulatory requirements.
Publication Source: Committees on Human Research
See also: Site Visit
Observations made by measurement in accordance with a defined method and plan to provide evidence of the performance of an installation.
NOTE: This information may be used to detect trends in operational state and to provide process support.
Publication Source: ISO/TC209 Working Groups at 2001-03-31 – Committee Draft ISO/CD 14644-6 “Cleanrooms and associated controlled environments” – Part 6: Terms and Definitions
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