Glossary

For “Direct Impact” systems, the documented verification that all aspects of a facility, utility or equipment that can affect product quality adhere to approved specifications (e.g., construction, materials) and is correctly installed.

The documented verification that the facilities, systems and equipment, as installed or modified,comply with the approved design and the manufacturer’s recommendations.

(FDA) Establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturer's recommendations are suitably considered.

Establishing documented evidence that the key aspects of the purchased item or installation conform to approved written specifications and/or drawings.

Documented verification that a system is installed according to written and pre-approved specifications.

Documented verification that all aspects of a facility or system, that can affect product quality, adhere to approved specifications and are correctly installed.

Filter system mounted in the ceiling, wall, apparatus or duct.

Test performed to confirm that the filters are properly installed by verifying that there is absence of bypass leakage in the installation, and that the filters and the grid system are free of defects and leaks.

A single installation of a software application (plus associated databases, tools and utilities). Usually applied to configurable IT systems.

An organization involved in the generation and promulgation of standards. IEEE standards represent the formalization of current norms of professional practice through the process of obtaining the consensus of concerned, practicing professionals in the given field.

(From Code of Federal Regulations) "Any public or private entity or agency (including federal, state, and local agencies)" 45CFR46.102 (b)

IRBs review, approve, and monitor research involving human subjects in order to evaluating the ethical acceptability and the scientific validity of any such studies. An IRB is formally designated by an institution in which research takes places, such as a hospital or university. FDA regulations on IRB membership are quite strict. The IRB must be composed of at least five members including at least one scientific member, one nonscientific member, at least one person not affiliated with the research institution, no members with conflicts of interests, both genders if at all possible, and so forth. Research cannot begin until the IRB approves.

Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home).

Persons who are confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled (e.g., a psychiatric hospital, home, or school for the retarded).

(ANSI/IEEE) A program statement that causes a computer to perform a particular operation or set of operations.

(ISO) In a programming language, a meaningful expression that specifies one operation and identifies its operands, if any.

(IEEE) The complete set of instructions recognized by a given computer or provided by a given programming language.

(ISO) The set of the instructions of a computer, of a programming language, or of the programming languages in a programming system.

Device or devices used to carry out a measurement.