Glossary

A system that fails to meet one or more of the requirements that set the criteria for a closed system.

A system that fails to meet one or more of the requirements that set the criteria for a closed system.

A study in which the investigator and the study participant are aware of the drug therapy received during the study.

All outside influences that interface with the computer system.

The minimum and/or maximum values that will ensure that product and safety requirements are met.

Any information entered into an automated system that is used for automated equipment operation.

A parameter indicative of the operating condition of a system.

Any information entered into an automated system used for automated equipment operation.

The validated acceptance criteria within which a control parameter must remain, wherein acceptable product is being manufactured.

(ISO) Software that controls the execution of programs, and that provides services such as resource allocation, scheduling, input/output control, and data management. Usually, operating systems are predominantly software, but partial or complete hardware implementations are possible.

The most important program run on a computer because it manages all the other programs. Operating systems perform basic tasks, such as recognizing input from the keyboard, sending output to the display screen, keeping track of files and directories on the disk, and controlling peripheral devices such as disk drives and printers. For large systems, the OS has even greater responsibilities and powers. It regulates traffic, making sure that different programs and users running at the same time do not interfere with each other. The operating system also is responsible for security, ensuring that unauthorized users do not access a system. Microsoft Windows NT, LINUX, and UNIX are operating systems.

Also known as working temperature, is the temperature that will be maintained in the metal of the part of the vessel being considered for the specified operation of the vessel (UG-20 and UG-23).

All factors of operation, including control parameters that may potentially affect process state of control and/or fitness for use of the product.

Each recipe step encompasses one or several functions. Operations stand for major treatment steps. An operation usually results into a chemical or physical transformation regarding the product. e.g., typical sequence of operations related to the production of PVC (Polyvinyl Chloride):•prepare reactor: set vacuum for eliminating O2;•load: fill with demineralized water and tension actives substances•initiate reaction: mix monomer of vinyl chloride and catalyst•heat (Tº set-point ranges 55ºC to 60ºC and maintain this set-point up to the pressure decrease

Room condition when normal process operations are undertaken.

Manuals detailing the operational and maintenance requirements for equipment.

(IEEE) The period of time in the software lifecycle during which a software product is employed in its operational environment, monitored for satisfactory performance, and modified as necessary to correct problems or to respond to changing requirements.

(IEEE) An exception that occurs when a program encounters an invalid operation code.

Documented verification that the equipment-related system or sub-system performs as intended throughout representative or anticipated operating ranges.

Condition where the installation is functioning in the specified manner, with the specified number of personnel present and working in the manner agreed upon”. ISO 14644-1, ISO 14644-3, ISO 14644-5, ISO 14698-1.

(ASTM E2500) Following system or facility acceptance, all changes related to specific requirements relative to product quality and patient safety require prior approval of the Quality Unit.

For “Direct Impact” systems, the documented verification that all aspects of a facility, utility, or equipment that can affect product quality, perform as intended throughout all anticipated operating ranges.

For “Direct Impact” systems, the documented verification that all aspects of a facility, utility, or equipment that can affect product quality, perform as intended throughout all anticipated operating ranges.

The documented verification that the facilities, systems and equipment, as installed or modified, perform as intended throughout the anticipated operating ranges.

(FDA) Establishing confidence that process equipment and sub-systems are capable of consistently operating within established limits and tolerances.