Glossary

Containing the table of content and the country specific translated information, in the official local language(s) of each country.

Safe, not contaminated.

(ICH Q10) The introduction of new technologies or methodologies.

Deliberately introduce something into. The process isinoculation. Not the same as contamination.1. In bacteriology, tissue culture, etc., placing inoculum into (or onto) medium to initiate a culture.2. In immunology, to immunize.

To introduce material to sensitize patients (as in vaccination).

1.Fermentation: an aliquot of a pure culture of microorganism added to the primary seed tank to initiate fermentation.2.Vaccines: an aliquot of a pure “culture” of virus to be added to either living tissue (e.g. chick embryo) or tissue in culture.

Material (usually cells) introduced into a culture medium.

A chemical compound that generally is not derived from living processes; compounds that do not contain carbon.

Chemical compounds which are not organic in nature. Inorganics that are soluble in water generally split into negative and positive ions, allowing their removal by deionization.

Any device that feeds data into a computer. In biometrics, it could be a fingerprint or a retinal scan.

(IEEE) A diagram of a software system or module, consisting of a rectangle on the left listing inputs, a rectangle in the center listing processing steps, a rectangle on the right listing outputs, and arrows connecting inputs to processing steps and processing steps to outputs.

A structured software design technique; identification of the steps involved in each process to be performed and identifying the inputs to and outputs from each step. A refinement called hierarchical input-process-output identifies the steps, inputs, and outputs at both general and detailed levels of detail.

Each microprocessor and each computer needs a way to communicate with the outside world in order to get the data needed for its programs and in order to communicate the results of its data manipulations. This is accomplished through I/0 ports and devices.

A type of chromosomal abnormality in which a DNA sequence is inserted into a gene, disrupting the normal structure and function of that gene.

(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.

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).

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.

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.

(ASME B31.3) The Owner, an employee of the Owner, an employee of an engineering or scientific organization, or of a recognized insurance or inspection company acting as the Owner’s agent that performs an inspection. The Owner’s Inspector shall not represent nor be an employee of the piping manufacturer, fabricator, or erector unless the Owner is also the manufacturer, fabricator, or erector. Owner’s Inspector shall be responsible for determining that a person to whom an inspection function is delegated is qualified to perform that function.

A person who is delegated by an owner’s inspector to perform inspection fiunctions as referenced in ASME B31.3, par. 340.4(c).

Insulin Receptor

(ANSI) The phase in the system lifecycle that includes assembly and testing of the hardware and software of a computerized system. Installation includes installing a new computer system, new software or hardware, or otherwise modifying the current system.

Cleanroom or one or more clean zones, together with all associated structures, air-treatment systems, services, and utilities. ISO 14644-1, ISO 14644-3.

(IEEE) The period of time in the software lifecycle during which a software product is integrated into its operational environment and tested in this environment to ensure that it performs as required.

Documented verification that all key aspects of hardware installation adhere to appropriate codes and approved design intentions, and that the recommendations of the manufacturer have been suitably considered.