Glossary

An evaluation process where the systems software functionality is assessed against the GxP, safety, and environmental critical parameters to enable accurate monitoring and control of the application during system development. The process uses a combination of system Risk Assessment and GAMP categorization of the system components.

Clinical research Information Exchange (FDA and NCI)

Customer Relationship Management

Corporate Records Management

Cosmetics Toxicology Branch (CFSAN)

CBER Regulatory Meetings Management Tracking System

Council for Responsible Nutrition

Contract Research Organization

Clinical Research Organization

In genetic studies, the mating of two individuals or populations. Also called mating.

The contamination of a drug substance or product by another.

(ICH Q7) Contamination of a material or product with another material or product.

The escape of a material from its intended place to someplace else where it may become an impurity in a different material.

The measurable and detrimental contamination of a drug substance or product by another.

(IEEE) An assembler that executes on one computer but generates object code for a different computer.

(IEEE) A compiler that executes on one computer but generates assembly code or object code for a different computer.

The egress of materials from one object to another object, person to person or from object to a person resulting in adulteration of a pharmaceutical formulation.

Contamination of a starting material, intermediate product or finished product with another starting material, intermediate material or product.

Legal, contractual procedure in which two or more firms with competing, similar technologies and possible conflicting patent claims strike a deal to reduce the need of legal actions to clarify who is to profit from applications of the technology.

Bench that is used as an aid to changing of cleanroom clothing and which provides a barrier to the tracking of floor contamination. ISO 14644-5.

A type of clinical trial in which each subject experiences, at different times, both the experimental and control therapy. For example, half of the subjects might be randomly assigned first to the control group and then to the experimental intervention, while the other half would have the sequence reversed.

The breaking during meiosis of one maternal and one paternal chromosome, the exchanging of corresponding sections of DNA, and the rejoining of the chromosomes. This process can result in an exchange of alleles between chromosomes.

A recombinant chromosome.

C-Reactive Protein

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