Glossary

A non-moving storage device utilizing one of a number of types of electronic circuitry to store information.

(IEEE) A software component that is called by the operating system of a computer and that usually calls other software components.

Term used to describe a large computer.

(IEEE) The ease with which a software system or component can be modified to correct faults, improve performance or other attributes, or adapt to a changed environment. Synonymous: Modifiability.

Ease with which maintenance can be performed.

(QA) Activities such as adjusting, cleaning, modifying, overhauling equipment to assure performance in accordance with requirements. Maintenance to a software system includes correcting software errors, adapting software to a new environment, or making enhancements to software.

Maintenance practices utilized on non-cGMP systems. These practices include: unique system or component identification, preventive maintenance, some level of documentation, and recordkeeping.

Those practices that go beyond Maintenance Good Practices. Maintenance Best practices may include: reliability engineering, enhanced controls, trending and analysis, benchmarking, etc.

The recommended maintenance requirements for the pharmaceutical industry to comply with cGMP in order to assure and document that the quality, safety, identity, purity, and strength of drugs or drug ingredients will not be compromised due to maintenance activities or lack of maintenance. Maintenance Good Practices encompasses Maintenance Basic Practices.

Tracks and directs the activities to maintain the equipment and tools to ensure their availability for manufacturing and ensure scheduling for periodic or preventive maintenance. Also provides the response (alarms) to immediate problems. It maintains a history of past events or problems to aid in diagnosing problems.

The specific maintenance instructions or tasks resulting from the System Maintenance Strategy that are performed on components, equipment, or systems.

A document prepared by the Maintenance Unit and approved by the Quality Unit describing the approach that a company will use with respect to all aspects of performing maintenance. The Maintenance Program outlines the policies for: System Maintenance Strategy, Maintenance Plans; Discrepancies; Change Management; Roles and Responsibilities; Documentation; Training; Equipment Identification; Continuous Improvement; etc.

A documented policy that describes a company’s approach to performing maintenance. The Maintenance Strategy would include descriptions of the management processes and philosophies to assure that assets fulfill their necessary functions

The organizational element responsible for developing and executing maintenance processes

Minimum Auto-Ignition Temperature

The location at which equipment is connected or disconnected.

External air introduced to the air handling system for ventilation and pressurization.

Material Air Lock

Matrix-Assisted Laser Desorption-Ionization

A structural defect inherited in an organ or part of an organ that result from abnormal fetal development.

Having the properties of cancerous growth.

Multiple-Angle Light Scattering

Metropolitan Area Network

Ultimately responsible to the regulator and authorities for the compliant operation of the EDA, including where third parties are being used. Financially responsible to the company owner.