Glossary

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.

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

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

(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.

A feature of the audit trail that aids both originator and reviewer in understanding why the originator performed a specific action. CFR 21 Part 11 does not require entering the reason for a record change, but some predicate rules (such as GLPs) do expect an explanation. It is important that the user interface for entering audit comments prevents users from changing the audit trail itself.

A written evaluation by the sponsor's auditor of the results of the audit.

Documentation that allows reconstruction of the course of events.

A sequence of steps supported by proof documenting the real processing of a transaction flow through a process or system.

(ISO) Data in the form of a logical path linking a sequence of events, used to trace the transactions that have affected the contents of a record.

A chronological record of system activities that is sufficient to enable the reconstruction, reviews, and examination of the sequence of environments and activities surrounding or leading to each event in the path of a transaction from its inception to output of final results.

Chain of related documents, or entries within records, that allows related information to be traced.

A computer-generated and time-stamped record of who did what, when. CFR 21 Part 11 requires audit trails to be generated independently of operators. An audit trail must capture all activities related to creating, modifying, and destroying records on a system.

An alternative surface analysis that can detect all elements with an atomic number greater than that of helium with the additional ability to analyze sub micron-diameter features. It is not as quantitative as ESCA and cannot determine the chemical state of an element. The primary advantage of Auger is that when combined with etching, a chemical depth profile can be measured rapidly and can image the distribution on the surface of spatial limitation resolution of 100 to 1,000 angstroms (depending on the equipment capability).

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The non-magnetic form of iron characterized by a face-centered cubic lattice crystal structure. It is produced by heating steel above the upper critical transformation temperature and has a high solid solubility for carbon (about 2%) and alloying elements.

The process of identifying a person, system, or company sufficiently to allow access to a system or part of a system.

Also known as authority checks, or authorized signers are mechanisms distinct from authorization that grants or denies access to a network resource, authentication programs are used by system administrators to establish and verify as conclusively as possible that a person logging in to the network is who he or she claims to be. FDA says that “authority checks” are to “ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system, input or output device, alter a record, or perform operations”.

In the context of electronic records, the quality of actually being what they purport to be. It implies that provenance can be established and the integrity of the original record is preserved.

In the context of electronic records, the quality of actually being what they purport to be. It implies that provenance can be established and the integrity of the original record is preserved.