Glossary

The design stage where various alternatives are generated for evaluation. After selection of concepts, functional design will follow.

Design stage, to generate various alternatives for evaluation. The project team then selects the concepts to be taken forward into the functional design stage.

Estimate developed from the use of parametric or factoring techniques to account for the limited amount of design information available.

Curved concavities or convexities shaped like the inside surface of a bivalve shell.

A medicinal product that is administered to a clinical trial participant as part of their standard of care for a condition that is not the indication for which the IMP is being tested. The concomitant medication is not the object of the study, and therefore, can be considered a NIMP.

Type of non-IMP (Investigational Medicinal Product) given to clinical trial participants as required in the protocol as part of their standard care for a condition which is not the indication for which the IMP is being tested, and is therefore not the obj

A medicine that is given with another therapy, either to improve the effect of the therapy or to manage a side effect. This is common in oncology protocols, but is also used in other therapeutic areas, such as to treat depression.

The manufacture of more than one product in a facility at the same time, with adequate separation to prevent cross contamination.

Establishing documented evidence that a process does what it purports to do based on information generated during actual implementation of the process.

Two or more products being processed at the same time.

(FDA – 2011) Releasing for distribution a lot of finished product, manufactured following a qualification protocol, that meets the lot release criteria established in the protocol, but before the entire study protocol has been executed.

Substance capable of depositing on a surface by condensation under cleanroom operating conditions.

Distillate just after it has been cooled from steam into the liquid state.

Instrument that is capable of enlarging ultrafine particles by means of condensation for subsequent counting using optical particle counting techniques.

The heat exchanger used in distillation to cool steam in order to convert it from the vapor to the liquid state.

A test coverage criteria requiring enough test cases such that each condition in a decision takes on all possible outcomes at least once, and each point of entry to a program or subroutine is invoked at least once.

A measure of flow of electrical current through water. This conductance is high with high Total Dissolved Solids (TDS) water and very low with ultrapure deionized water. Conductivity is the reciprocal of resistivity (C=1/R) and is measured in micromho/cm (µmho/cm) or microsiemens/cm (µS/cm).

A measure of flow of electrical current through water. This conductance is high with high Total Dissolved Solids (TDS) water and very low with ultrapure deionized water. Conductivity is the reciprocal of resistivity (C=1/R) and is measured in micromho/cm (µmho/cm) or microsiemens/cm (µS/cm).

The reciprocal of resistivity (C=1/R). A measure of the ability to conduct an electric current. Since ionized impurities increase the conductivity of water, it is also an accurate measure of ionic purity. Conductivity is normally expressed in micromhos/cm (µmho/cm) or microsiemens/cm (µS/cm). To measure it, current is passed between two electrodes a fixed distance apart.

Participating parties are required to keep all non-public information in confidence and will not, without prior written consent, disclose the information to any person or entity, except those of parties involved such as officers, employees, agents, and representatives.

The protection of individually identifiable information as required by state and federal legal requirements and Partners policies.

In genetics, the expectation that genetic material and the information gained from testing that material will not be available without the donor’s consent.

Commercial, off-the-shelf software that can be configured to specific user applications without altering the basic program.

Application software, sometimes general purpose, written for a variety of industries or users in a manner that permits users to modify the program to meet their individual needs.

(IEEE) The arrangement of a computer system or component as defined by the number, nature, and interconnections of its constituent parts.