Operational Qualification definition

Operational Qualification means, where listed on the Accepted Quote, the procedure which may follow Site Sign Off to test the operation of both Checkit and the Monitored Equipment, resulting in Cloud Sign Off;

Operational Qualification means the demonstration of whether a facility, process equipment and sub-systems are capable of consistently operating within established limits and tolerances by testing (at upper and lower operating limits) compliance with the requirements identified in the corresponding design specifications for such facility, individual equipment, or sub-system and confirming whether any newly acquired equipment (or facilities, services or systems) functions as expected, that all parts and components operate correctly, that all controls perform the intended function and that all gauges and indicators are calibrated and display the correct value. Operational Qualification should follow on from the installation of the equipment and sub-systems and should include tests that have been developed based on detailed knowledge of equipment, systems or processes.

Operational Qualification has the meaning specified in Annex 15 to the EU Guide to Good Manufacturing Practice (EUDRALEX Volume 4).

Examples of Operational Qualification in a sentence

• Operational Qualification: Verification that equipment will function according to the operational specifications provided by the manufacturer.

• Qualification: User Requirement Specification, Design Qualification, Factory Acceptance Test (FAT)/ Site Acceptance Test (SAT), Installation Qualification, Operational Qualification, Performance Qualification, Re- Qualification (Maintaining status- Calibration Preventive Maintenance, Change management), Qualification of Manufacturing Equipments, Qualification of Analytical Instruments and Laboratory equipments.

• Training shall include Operational Qualification of engineers and controllers to perform daily operations and anomaly investigation.

• Installation Qualification, Operational Qualification and Instrument Performance Verification are available upon the Customer’s request at any time during the term of the Agreement.

• UNIT - IIQualification: User Requirement Specification, Design Qualification, Factory Acceptance Test (FAT)/ Site Acceptance Test (SAT), Installation Qualification, Operational Qualification, Performance Qualification, Re- Qualification (Maintaining status-Calibration Preventive Maintenance, Change management),Qualification of Manufacturing Equipments, Qualification of Analytical Instruments and Laboratory equipments.

More Definitions of Operational Qualification

Operational Qualification means a process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures; and

Operational Qualification means that the Facility works in a manner which is compliant with relevant regulatory guidelines such as Annex 15 of the EU Guide to Good Manufacturing Practice. It permits the formal release of the Facility, systems and equipment following the finalization of calibration, operating and cleaning procedures, operator training and preventative maintenance systems as documented through approved protocols and reports.

Operational Qualification means the documented demonstration or verification of whether a facility, process equipment and sub-systems, as installed or modified, perform as intended throughout anticipated operating ranges. Such performance may include whether such systems are capable of consistently operating within established limits and tolerances by testing (at upper and lower operating limits) compliance with the requirements identified in the corresponding design specifications for such facility, individual equipment, or sub-system and confirming whether any newly acquired equipment (or facilities, services or systems) functions as expected, that all parts and components operate correctly, that all controls perform the intended function and that all gauges and

Operational Qualification means validation that equipment performance is consistent with the user requirement specification within the manufacturer specific operating ranges (i.e., identifying and inspecting equipment features that can impact the Product quality).

Operational Qualification means the documented demonstration or verification of whether a facility, process equipment and sub-systems, as installed or modified, perform as intended throughout anticipated operating ranges. Such performance may include whether such systems are capable of consistently operating within established limits and tolerances by testing (at upper and lower operating limits) compliance with the requirements identified in the corresponding design specifications for such facility, individual equipment, or sub-system and confirming whether any newly acquired equipment (or facilities, services or systems) functions as expected, that all parts and components operate correctly, that all controls perform the intended function and that all gauges and indicators are calibrated and display the correct value. Operational Qualification should follow on from the installation of the equipment and sub-systems and should include tests that have been developed based on detailed knowledge of equipment, systems or processes. Following successful completion of the Operational Qualification activities, development batches may be run in preparation for the facility validation activities.

Operational Qualification has a definition compliant with relevant regulatory guidelines such as Annex 15 of the EU Guide to Good Manufacturing Practice. It permits the formal release of the facilities, systems and equipment following the finalization of calibration, operating and cleaning procedures, operator training and preventative maintenance systems as documented through approved protocols and reports.

Operational Qualification means the documented verification required to comply with cGMP Requirements that the equipment and ancillary systems used in the Manufacturing Process perform as intended throughout anticipated operating ranges;