ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Audit

(ISO) Systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled.

Publication Source: GAMP® 4: Good Automated Manufacturing Practice Guide for Validation of Automated Systems

Audit

(IEEE) An independent examination of a work product or set of work products to assess compliance with specifications, standards, contractual agreements, or other criteria.

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

See also: Functional Configuration Audit Physical Configuration Audit

Audit

(ANSI) To conduct an independent review and examination of system records and activities in order to test the adequacy and effectiveness of data security and data integrity procedures, to ensure compliance with established policy and operational procedures, and to recommend any necessary changes.

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

See also: Computer System Audit Software Audit

Audit

(of a clinical trial). A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).

Publication Source: Committees on Human Research

Audit

An on-site evaluation by an ASME appointed team to review and report evidence of compliance of the applicant with regard to the requirements of the ASME BPE Standard, “after” issuance of a certificate.

Publication Source: American Society of Mechanical Engineers (ASME), Bioprocessing Equipment (BPE) - 2009 Revision

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