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;
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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.
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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
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Examples of Operational Qualification in a sentence

  • 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 Equipment, Qualification of Analytical Instruments and Laboratory equipments.

  • 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.

  • These were back-analysed to calibrate the model with actual behaviour.

  • The system should have Q3 certificate i.e. Installation Qualification, Performance Qualification and Operational Qualification on the site.

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

  • Depending on the Products delivered and as agreed between the parties, Tecan may perform an Installation Qualification as well as support an Operational Qualification at the premises of the customer.

  • Selected company must provide a complete protocol for validation of the system in relation to Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

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

  • All of Immucor’s obligations under this Service Plan (with the exception of the AIS System) are conditioned on customer’s installation and commencement of use of Immucor’s remote instrument diagnostic communication tool referred to as “blud_direct” within twelve (12) months of customer evidencing acceptance of the Instrument by executing Immucor's Operational Qualification Certificate for the serial number of the Instrument.

  • Customer will execute an Operational Qualification Certificate when Immucor has completed installation.


More Definitions of Operational Qualification

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.
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Operational Qualification has the meaning specified in Annex 15 to the EU Guide to Good Manufacturing Practice (EUDRALEX Volume 4).
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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;
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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.
Sample 1
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 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 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.
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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).
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Related to Operational Qualification

  • Minimum Qualifications are qualifications mandated for the position and which must be possessed by an employee before he/she can be considered for employment in a specific class.

  • pre-qualification means the first stage of the Bidding Process involving the submission, opening and evaluation of the Qualification Documents submitted by the Prospective Bidders.

  • Monthly Qualification Cycle means a period beginning one (1) day prior to the first day of the current Statement Cycle through one (1) day prior to the close of the current Statement Cycle.

  • Request For Qualifications (RFQ means the written solicitation, including all Addenda thereto, issued by the Department seeking SOQs in order to identify and Short-List the Proposers to receive the RFP for the Project.

  • Request for Qualifications means all materials and

  • Statement of Qualifications means a written statement submitted to a procurement unit in response to a request for statement of qualifications.

  • Qualification Date means the date as of which the Offering Statement was or will be qualified with the Commission pursuant to Regulation A, the Act and the Rules and Regulations; and

  • Qualification Period means the period of time in which the List of Approved Suppliers shall be valid in accordance with the Tender; in which the Company shall have the right, at any time to issue Purchase Order(s) for Goods and/or to approach any or all of the Approved Suppliers and invite them, by way of RFQ to supply Goods, all in accordance with the terms and conditions of the Contract.

  • Prequalification means the process set out in the Rules for determining whether an applicant is eligible to bid in a capacity auction in respect of a CMU;

  • National Ambient Air Quality Standards or “NAAQS” means national ambient air quality standards that are promulgated pursuant to Section 109 of the Act, 42 U.S.C. § 7409.

  • Data qualifier means a specified character (or string of characters) that immediately precedes a data field that defines the general category or intended use of the data that follows.

  • Qualification Requirements means the qualification requirements as set forth in Section-2, Clause 2.1 of RFQ;

  • Qualification means any degree, diploma or certificate conferred upon a person after having been examined in respect of that person’s proficiency in a particular field of study;

  • Regional integration organization means an organization constituted by sovereign States of a given region, to which its member States have transferred competence in respect of matters governed by this Convention. Such organizations shall declare, in their instruments of formal confirmation or accession, the extent of their competence with respect to matters governed by this Convention. Subsequently, they shall inform the depositary of any substantial modification in the extent of their competence.

  • Regional economic integration organization means an organization constituted by sovereign States of a given region to which its member States have transferred competence in respect of matters governed by this Convention and which has been duly authorized, in accordance with its internal procedures, to sign, ratify, accept, approve or accede to this Convention;

  • Stewardship organization means an organization, association, or

  • Impermissible Qualification means, relative to the opinion or certification of any independent public accountant as to any financial statement of any Obligor, any qualification or exception to such opinion or certification

  • Electric Reliability Organization or “ERO” means the organization that is certified by the Commission under Section 39.3 of its regulations, the purpose of which is to establish and enforce Reliability Standards for the Bulk Power System in the United States, subject to Commission review. The organization may also have received recognition by Applicable Governmental Authorities in Canada and Mexico to establish and enforce Reliability Standards for the Bulk Power Systems of the respective countries.

  • General air quality operating permit or "general permit" means an air quality operating permit that meets the requirements of ARM 17.8.1222, covers multiple sources in a source category, and is issued in lieu of individual permits being issued to each source.

  • Regional Board means a California regional water quality control board.

  • Qualified airport authority means an airport authority

  • Public or private safety agency means a unit of state or local government, a special purpose district, or a private firm, which provides or has the authority to provide firefighting, police, ambulance, emergency medical services or hazardous materials response.

  • Individual Resource Status Single Dwelling Contributing Total: 1

  • service delivery and budget implementation plan means a detailed plan approved by the executive mayor of a municipality in terms of section 53(l)(c)(ii) of the MFMA for implementing the municipality's delivery of municipal services and its annual budget, and which must indicate

  • Minimum Annual Resource Requirement means, for Delivery Years through May 31, 2017, the minimum amount of capacity that PJM will seek to procure from Annual Resources for the PJM Region and for each Locational Deliverability Area for which the Office of the Interconnection is required under Tariff, Attachment DD, section 5.10(a) to establish a separate VRR Curve for such Delivery Year. For the PJM Region, the Minimum Annual Resource Requirement shall be equal to the RTO Reliability Requirement minus [the Sub-Annual Resource Reliability Target for the RTO in Unforced Capacity]. For an LDA, the Minimum Annual Resource Requirement shall be equal to the LDA Reliability Requirement minus [the LDA CETL] minus [the Sub-Annual Resource Reliability Target for such LDA in Unforced Capacity]. The LDA CETL may be adjusted pro rata for the amount of load served under the FRR Alternative.

  • National Pollutant Discharge Elimination System Permit or “NPDES” means a permit issued by the MPCA as required by federal law for the purpose of regulating the discharge of pollutants from point sources into waters of the United States from concentrated animal feeding operations (CAFOs) as defined by federal law