ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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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.”

Publication Source: ISPE Baseline® Guide, Vol. 2: Oral Solid Dosage Forms (Second Edition)

Publication Date: 2009


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

Publication Source: FDA Glossary of Computerized System and Software Development Technology

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