ISPE Glossary of Pharmaceutical and Biotechnology Terminology

Print this page         
Find Definition by Term and/or Language
Term Language (Optional)
Browse All Terms
Beginning With By Language
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z :: All English


A manual testing technique in which program documents [specifications (requirements, design), source code or user's manuals] are examined in a very formal and disciplined manner to discover errors, violations of standards and other problems. Checklists are a typical vehicle used in accomplishing this technique.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

See also: Code Audit Code Inspection Code Review Code Walkthrough Static Analysis


The process by which the construction and installation is verified as in accordance with the detailed design, specified construction standards and materials and any relevant legal or regulatory demands relating to these areas.

Publication Source: ISPE Baseline® Guide, Vol. 5: Commissioning and Qualification

Publication Date: 2001


The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other establishments deemed appropriate by the authority(ies).

Publication Source: Committees on Human Research


(ASME B31.3Any operation performed for the Owner by the Owner’s Inspector or the Inspector’s delegate(s) to assure that the piping materials, components, fabrication, and installation are in accordance to Code(s) and engineering design. Inspection may include review of certifications, welding procedure and welder qualifications, records of examinations and testing, and inspection of piping using any examination method that may be required by the engineering design.

Do you have a term that should be included in the glossary?
Submit a term for review


  • Click to go to My Communities of Practice
  • Click to go to My Affiliate or Chapter
  • Click to go to My Profile
Click to go to the Member Gift