Glossary

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.

Document designating permission. The HIPAA Privacy Rule requires authorization or waiver of authorization for the use or disclosure of identifiable health information for research (among other activities). The authorization must indicate if the health information used or disclosed is existing information and/or new information that will be created during the research. The authorization form may be combined with the informed consent form, so that a subject need sign only one form. An authorization must include the following specific elements: a description of what information will be used and disclosed and for what purposes; a description of any information that will not be disclosed, if applicable; a list of who will disclose the information and to whom it will be disclosed; an expiration date for the disclosure; a statement that the authorization can be revoked; a statement that disclosed information may be redisclosed and no longer protected; a statement that if the individual does not provide an authorization, s/he cannot receive research-related treatment; the subject's signature and date.

The person or company in whose name the marketing authorization has been granted. This party is responsible for all aspects of the product, including quality and compliance with the conditions of marketing authorization. The authorization holder must be subject to legislation in the country that issued the marketing authorization, which normally means being physically located in the country.

An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research.

An apparatus into which moist heat (steam) under pressure is introduced to sterilize or decontaminate materials placed within (e.g. filter assemblies, glassware, etc.). Steam pressure is maintained for pre-specified times and then allowed to exhaust. There are two types of autoclaves:1.Gravity displacement autoclave: this type of autoclave operates at 249.8ºF (121ºC). Steam enters at the top of the loaded inner chamber, displacing the air below through a discharge outlet.2.Vacuum autoclave: this type of autoclave can operate with a reduced sterilization cycle time. The air is pumped out of the loaded chamber before it is filled with steam.

An apparatus into which moist heat (steam) under pressure is introduced to sterilize or decontaminate materials placed within (e.g. filter assemblies, glassware, etc.).

A weld made by fusion of the base material without the addition of filler.

A disease in which the body produces an immunogenic response against self-antigens. In some cases, predominantly one organ is affected (e.g. hemolytic anemia and chronic thyroiditis); in others, the disease process is diffused through many tissues (e.g. SLE (Systemic Lupus Erythematosis)).

A human disease caused by failure of lymphocytes to die once they have finished doing their job. As a result, the spleen and lymph nodes grow large, and immune cells may attack the body's own tissues, a condition known as autoimmunity.

A condition in which the body mounts an immune response against one of its own organs or tissues.

In blood transfusion and transplantation, a situation in which the donor and recipient are the same person. Patients scheduled for non-emergency surgery may be autologous donors by donating blood for themselves that will be stored until the surgery.An autologous graft is providing a graft, for example of skin, to yourself.

Any facility system or piece of equipment that is controlled with limited or no manuel intervention.

A broad range of systems including, but not limited to, automated manufacturing equipment, automated laboratory equipment, process control, manufacturing execution, laboratory information management, manufacturing resource planning, clinical trials data management, and document management systems.The automated system consists of the hardware, software, and network components, together with the controlled functions and associated documentation. Automated systems are sometimes referred to as computerized systems.

Any facility system or piece of equipment that is PLC (Programmable Logic Controller) controlled or computer-controlled.

An automated/robotic method almost exclusively utilizes non-human, mechanical manipulations to prepare samples and analyze them. Typically, weighing, dilutions, filtering, and transferring are mechanically executed. Independent auto-injectors and auto-pipettors alone do not constitute an automated/robotic method.

Welding with equipment that performs the welding operation without adjustment of the controls by a welding operator. The equipment may or may not perform the loading and unloading of the work.

The creation and application of technology to monitor and control the production of goods and services. Intrinsic to automation is instrumentation and basic control* dedicated to establishing and maintaining a specific state of equipment or process condition. *Ref ISA S88.01-1995 Part 1: Models and Terminology

Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others.

Examination by dissection of the body of an individual to determine cause of death.

A technique that captures the image formed in a photographic emulsion as a result of the emission of either light or radioactivity from a labelled component that is placed next to unexposed film. The technique is used for detecting the location of an isotope in a tissue, cell or molecule. The sample is placed in contact with a photographic emulsion, usually an X-ray film.The emission of beta-particles from the sample activates the silver halide grains in the emulsion and allows them to reduce to metallic silver when the film is developed. In genetic engineering, autoradiography is most commonly used to detect the hybridization of a radioactive DNA (probe) molecule to denatured DNA in either the Southern transfer or colony hybridization procedures.