Glossary

(ISO) a group of related data elements treated as a unit.

A data element (field) is a component of a record, a record is a component of a file (database).

The stages through which a record passes during its life. Typically, these are: Creation, Active Use, Semi-Active/Inactive Use, and Final Disposition (such as deletion).

Documentation of changes made to the system. A record of change can be a written document or a database. Normally there are two associated with a computer system, hardware and software. Changes made to the data are recorded in an audit trail.

(ISO) Storing and retaining quality records in an established and recorded period of time in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Records may be in the form of any type of media, such as hard copy or electronic media.

In bioprocessing: the recovery of product from the cell culture medium.In HVAC: the time required for a cleanroom to go from “in-use” airborne conditions at “at-rest” conditions.

Any treatment of materials by a process intended to make them suitable for further use.

Loading of backed-up data onto a computer system to recover from a problem.

The time required for a cleanroom to go from “In-use” airborne conditions to at “at-rest” conditions after operations are terminated and personnel removed.

The time after an upset in a room’s HVAC environmental parameters for the room to return to “normal” conditions, such as a return to acceptable humidity levels after a room wash down. This occurs within a certain number of air changes after the upset source is removed, minimally six to ten, depending on the severity of the upset, the quality of the air supply, and the degree of mixing of room air.

Processes used to attract and enroll trial participants according to eligibility criteria.

A process in which a software module calls itself.

(IEEE) The process of defining or generating a process or data structure in terms of itself.

Reduction Equivalent Dose

Focuses on pharmaceutical and medical applications; main products are pharmaceutically active proteins such as hormones and antibodies.

Computer architecture that reduces the complexity of the chip by using simpler instructions. Reduced instruction set does not necessarily mean fewer instructions, but rather a return to simple instructions requiring only one or a very few instruction cycles to execute, and therefore are more effectively utilized with innovative architectural and compiler changes. Systems using RISC technology are able to achieve processing speeds of more than five million instructions per second.

A molecule that donates an electron in an oxidation-reduction reaction. That reaction is a chemical change in which one species is oxidized (loses electrons) and another species is reduced (gains electrons).

In automation, an array configuration and applications for multiple independent disk drives as if they were one large disk. RAID provides a method of accessing multiple disks as if they were one large disk. RAID is typically used for file serves, transaction of application servers, where data accessibility is critical, and where fault tolerance is required.

also see: Comparator Product

(ICH Q7) A substance that has been shown by an extensive set of analytical tests to be authentic material that should be of high purity. This standard can be: (1) obtained from an officially recognized source, or (2) prepared by independent synthesis, or (3) obtained from existing production material of high purity, or (4) prepared by further purification of existing production material.

(ICH Q7) A substance of established quality and purity, as shown by comparison to a primary reference standard, used as a reference standard for routine laboratory analysis.

(ICH Q6B) Refer to international or national standards.

Relationship between records that ensures data integrity by maintaining unbreakable links between related electronic records. It ensures confidence that a specific record (such as a calculated chromatographic result) is unmodified, unmanipulated, and otherwise uncorrupted after its creation and that still carries the references to the other electronic records that were used to generate it.

A second pass weld made to correct a lack of fusion or missed joint.

Fluids used for heat transfer in a refrigerating system; the refrigerant absorbs heat and transfers it at a higher temperature and higher pressure, usually with a change of state. Refrigerants can be:1.Primary refrigerants. Liquids with low boiling points that change from a liquid to a gas after absorbing heat.2.Secondary refrigerants. Substances that act only as heat carriers, such as brine, air, and water.