Glossary

Computer Systems Validation

Confirmation by examining and providing objective evidence that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled.


Functional Genomics

Applying genomic information to determine gene function, commonly using microarrays and model organisms. An important part of target validation.


Methods Validation

Establishing, through documented evidence, a high degree of assurance that an analytical method will consistently yield results that accurately reflect the quality characteristics of the product tested.


Process Validation

Establishing, through documented evidence, a high degree of assurance that a specific process will consistently yield a product that meets predetermined specifications and quality characteristics.


Small Molecule Library

A collection of prepared small molecule compounds. Such libraries are maintained in order to facilitate screening and target validation. Small molecules interacting favorably with a target may become drug compound candidates, and so the target may become validated.


Target Validation

The process of demonstrating that a drug interacting with a given target could have a therapeutic effect.


Validation

The establishment of documented evidence (for example, data derived from rigorous testing) that provides a high degree of assurance that a specific process or system will consistently yield a product meeting predetermined specifications and quality attributes.


Validation batches

Validation batches are commercial scale batches that are manufactured consecutively in order to validate a process according to a validation protocol that was developed and authorized.

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