Glossary

(ICH Q7) The record of the individual who performed a particular action or review. This record may be initials, full handwritten signature, personal seal, or authenticated and secure electronic signature.

An investigational device that:(1)It is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject.(2)It is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject.(3)It is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.(4)Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Safety Integrity Level

System Implementation Life Cycle

Silicon Dioxide (SiO2) and its hydrated forms classed as reactive and nonreactive. Generally, reactive silica is removed by the anion exchange resin. Reactive silica is only slightly ionized and is held lightly by the anion resin. It is for this reason that silica is the first thing to break through when the resin nears exhaustion. Non-reactive silica is generally considered particulate (colloidal) in nature.

Silicon dioxide, SiO2, occurring naturally in crystalline, microcrystalline, and amorphous form; used to make glass and ceramics, and is used in pharmaceuticals. Silica gel is a jelly-like form of silicon dioxide that is widely used as a solid medium, as a dehumidifying and dehydrating agent, and in many chemical processes.

Society for Industrial Microbiology

(NBS) Use of an executable model to represent the behavior of an object. During testing the computational hardware, the external environment, and even code segments may be simulated.

(IEEE) A model that behaves or operates like a given system when provided a set of controlled inputs.

(IEEE) A software V&V task to simulate critical tasks of the software or system environment to analyze logical or performance characteristics that would not be practical to analyze manually.

(IEEE) A device, computer program, or system that behaves or operates like a given system when provided a set of controlled inputs. A simulator provides inputs or responses that resemble anticipated process parameters. Its function is to present data to the system at known speeds and in a proper format.

Sindbis Virus

Short interspersed nuclear elements. Families of short (150 to 300 bp), moderately repetitive elements of eukaryotes, occurring about 100,000 times in a genome. SINES appear to be DNA copies of certain tRNA molecules, created presumably by the unintended action of reverse transcriptase during retroviral infection.

Hereditary disorder caused by a mutant allele of a single gene (e.g., Duchenne muscular dystrophy, retinoblastoma, sickle cell disease).

Material derived on one or more occasions from a single production cell culture inoculated with the same working seed lot or a suspension derived from the working seed lot, incubated, and harvested in a single production run.

A label with just one layer; affixed directly onto the container containing one or more languages limited by size.

(also see: Disposables)

(also see: Disposables)

Typically, a study design in which the investigator, but not the subject, knows the identity of the treatment assignment. Occasionally the subject, but not the investigator, knows the assignment. Sometimes called "single-masked design".

A study in which the treatment group assignment is not revealed to the study participant but is known by the investigator.

Cells or protein extracts from microorganisms, grown in large quantities for use as protein supplements.

(SNP; pronounced “snip”) A polymorphism at a particular base site in a coding sequence, e.g., at base 306 in a particular gene, one individual could be heterozygous for A and G: the maternal allele could have an A at this site, while the paternal allele has a G at this site. This type of polymorphism is extensive throughout the genome, and has the great advantage of being detectable without the need for gel electrophoresis, which opens the way for largescale automation of genotyping.

Converting powder into a continuous mass by heating to a temperature considerably below fusion, usually after preliminary compacting by pressure.

Submission Information Package (OAIS)

Sterilize-In-Place