ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Inspection

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

Inspection

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

Inspection

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

Inspection

(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.

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