Glossary

Ring seal of circular cross section.

Oxygen-Arc Cutting

Official Action Indicated (FDA)

Open Archival Information System

Organization for the Advancement of Structured Information Standards

This should be understood in the sense of any physical or logical entity for which the process control systems offers control modes and records identified data, e.g., the cleanliness of a pipe, availability status of a centrifuge, automatic control mode of a recipe, automatic mode of a fluid transfer, or manual control mode of a reactor.The IEEE Recommended Practice for Software Requirements Specifications – IEEE Std 830-1998 reads: “Objects are real-world entities that have a counterpart within the system. For example, in a patient monitoring system, objects include patients, sensors, nurses, rooms, physicians, medicines, etc. Associated with each object is a set of attributes (of that object) and functions (performed by that object). These functions are also called services, methods, or processes. When organizing this section by object, the outline in A.4 should be used. Note that sets of objects may share attributes and services. These are grouped together as classes.”

In object oriented programming, a self-contained module (encapsulation) of data and the programs (services) that manipulate (process) that data.

(NIST) A code expressed in machine language ("1"s and "0"s) which is normally an output of a given translation process that is ready to be executed by a computer. Synonymous: Machine Code.

A database management system specifically designed to manage and store complex objects and their complex relationships; that is, such items are stored as objects rather than as tables or fields. They support modeling and creation of data as objects, allowing for greater flexibility in tracking parent method sets and subcomponents. Such systems may be better than relational database management systems at meeting the data integrity requirements of CFR 21 Part 11.

(IEEE) A software development technique in which a system or component is expressed in terms of objects and connections between those objects.

(IEEE) A programming language that allows the user to express a program in terms of objects and messages between those objects. Examples include C++, Smalltalk and LOGO.

A technology for writing programs that are made up of self-sufficient modules that contain all of the information needed to manipulate a given data structure. The modules are created in class hierarchies so that the code or methods of a class can be passed to other modules. New object modules can be easily created by inheriting the characteristics of existing classes.

(IEEE) A computer program that is the output of an assembler or compiler.

Oxygen Cutting

Operational Change Control

The purpose for which a building or part thereof is used or intended to be used.

The specific exposure control objectives to maintain at all times point-source air concentrations of active ingredients at or below specific measurements through the use of engineering controls, and to prevent migration of particulate out of the process rooms through the use of process and facility engineering controls, and good work practices. OELs are usually established late in clinical development and they are based on Time Weighed Average (TWA), average employee exposure of his/her breathing zone (the air around nose and mouth) to concentration of compounds for 8 hours, 40 hours per week. They may include a Short-Term Exposure Limit (STEL) for compounds with acute effects, and they are normally supported with an industrial hygiene sampling method.

An OEL is a health-based airborne concentration limit to which worker exposure levels should be controlled. Limits are usually expressed as eight-hour time weighted averages for exposures for 40 hours a week over a working lifetime.

Office of Combination Products (FDA)

Organic Chemicals, Plastics, and Synthetic Fiber

Optical Character Recognition