Installation Qualification definition

Installation Qualification provides verification and documentation that the equipment is properly installed at the Property, that the materials of construction meet cGMP requirements and that the equipment is properly connected to utilities and controls according to the vender and engineer specifications.
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Installation Qualification has the meaning specified in Annex 15 to the EU Guide to Good Manufacturing Practice (EUDRALEX Volume 4).
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Installation Qualification means the verification that equipment being qualified has been installed and configured according to the manufacturer’s specifications or installation checklist.
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Examples of Installation Qualification in a sentence

  • Installation Qualification: Contractors for floor covering installation should be experienced in managing commercial flooring projects and provide professional installers, qualified to install the various flooring materials specified.

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  • 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.

  • The descriptions of these services are listed below: • Installation Qualification: documentation that facilities in which the instrument has been installed are in accordance with requirements and safety regulations of the original manufacturer.

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

  • 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.

  • 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.

  • Many of the programs with ✓’s did not initially include patient educator training in these methods, but introduced it later.

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

  • 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).


More Definitions of Installation Qualification

Installation Qualification means the program employed by Nordion by which it is established that the process equipment in question and ancillary systems are capable of consistently operating within established limits and tolerances.
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Installation Qualification means the program employed by I3 by which it is established that the equipment and systems used in the Process are capable of consistently operating within established limits and tolerance for purposes of Processing the Product for use in Clinical Trials.
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Installation Qualification means the documented qualification, based on objective evidence provided by CIPAN to Paratek in either written or oral form, that the installation of process equipment and ancillary systems has been completed in accordance with the manufacturer’s approved specifications and any recommendations provided by the supplier of the equipment with respect to such installation (or, if any such recommendation has not been adopted, CIPAN shall provide objective evidence of their good faith consideration to such recommendation). CIPAN shall provide written evidence to Paratek that the equipment and its ancillary systems or sub-systems have been installed in accordance with installation drawings or specifications established by the Parties for the New Facility Area. For the avoidance of doubt, [***].
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Installation Qualification will mean the documented verification (i.e., supporting documentation must be in place and of suitable quality) that all aspects of the Facility excluding Punch Lists Items (including, without limitation, the Utilities and the Equipment) that can affect achievement of Operation Qualification, Performance Qualification and Process Validation are installed correctly and in accordance with design documentation requirements (including, without limitation, specifications, purchase orders, contracts, and bid packages).
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Installation Qualification means the documented verification required to comply with cGMP Requirements that all key aspects of the installation of the equipment and ancillary systems used or to be used in the Manufacturing Process adhere to the approved designs and the recommendations of the manufacturer;
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Installation Qualification means the documented qualification, based on objective evidence provided by CIPAN to Paratek in either written or oral form, that the installation of process equipment and ancillary systems has been completed in accordance with the manufacturer’s approved specifications and any
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Related to Installation Qualification

  • Nuclear installation means any installation of such class or description as may be prescribed by regulations made by the relevant Secretary of State from time to time by statutory instrument, being an installation designed or adapted for:

  • Installation means that the System or a Subsystem as specified in the Contract is ready for Commissioning as provided in GCC Clause 26 (Installation).

  • Type 1 Installation means any Technical Installation upon which all SW deployed is licensed for Use with, and is running on, such TPD;

  • Installation Site means the site at which the Product is originally installed.

  • water installation means the pipes and water fittings which are situated on any premises and ownership thereof vests in the owner thereof and used or intended to be used in connection with the use of water on such premises, and includes a pipe and water fitting situated outside the boundary of the premises, which either connects to the connection pipe relating to such premises or is otherwise laid with the permission of the municipality;

  • Type 3 Installation means any Technical Installation upon which none of the SW, or only a portion of the SW, deployed is licensed for Use with such TPD, and therefore a TPD is not deployed or running.

  • Installation Date means the date specified in the Statement of Work by which the Contractor must have the ordered Equipment ready (certified) for use by the State.

  • meter installation means the meter and, if so equipped, the instrument transformers, wiring, test links, fuses, lamps, loss of potential alarms, meters, data recorders, telecommunication equipment and spin-off data facilities installed to measure power past a meter point, provide remote access to the metered data and monitor the condition of the installed equipment;

  • Installation Services means all those services ancillary to the supply of the Plant and Equipment for the Facilities, to be provided by the Contractor under the Contract; e.g., transportation and provision of marine or other similar insurance, inspection, expediting, site preparation works (including the provision and use of Contractor’s Equipment and the supply of all construction materials required), installation, testing, pre-commissioning, commissioning, operations, maintenance, the provision of operations and maintenance manuals, training, etc.

  • Installation Information for a User Product means any methods, procedures, authorization keys, or other information required to install and execute modified versions of a covered work in that User Product from a modified version of its Corresponding Source. The information must suffice to ensure that the continued functioning of the modified object code is in no case prevented or interfered with solely because modification has been made.

  • Unfit-for-use tank system means a tank system that has been determined through an integrity assessment or other inspection to be no longer capable of storing or treating hazardous waste without posing a threat of release of hazardous waste to the environment.

  • Installation Work means the construction and installation of the System and the Start-up, testing and acceptance (but not the operation and maintenance) thereof; all performed by or for the Power Producer at the Premises.

  • Building, structure, facility, or installation means all of the pollutant-emitting activities which belong to the same industrial grouping, are located on one or more contiguous or adjacent properties, and are under the control of the same person (or persons under common control) except the activities of any vessel. Pollutant-emitting activities shall be considered as part of the same industrial grouping if they belong to the same major group (i.e., which have the same two-digit code) as described in the Standard Industrial Classification Manual, 1972, as amended by the 1977 Supplement (U.S. Government Printing Office stock numbers 4101-0066 and 003-005-00176-0, respectively).

  • Type 2 Installation means any Technical Installation upon which all SW deployed is licensed for Use with, but is not running on, such TPD; and,

  • Utility Installation means carpeting, window and wall coverings, power panels, electrical distribution systems, lighting fixtures, air conditioning, plumbing, and telephone and telecommunication wiring and equipment. At the expiration of the term, Lessor may require the removal of any or all of said alterations, improvements, additions or Utility Installations, and the restoration of the Premises and the Office Building Project to their prior condition, at Lessee's expense. Should Lessor permit Lessee to make its own alterations, improvements, additions or Utility Installations, Lessee shall use only such contractor as has been expressly approved by Lessor, and Lessor may require Lessee to provide Lessor, at Lessee's sole cost and expense, a lien and completion bond in an amount equal to one and one-half times the estimated cost of such improvements, to insure Lessor against any liability for mechanic's and materialmen's liens and to insure completion of the work. Should Lessee make any alterations, improvements, additions or Utility Installations without the prior approval of Lessor, or use a contractor not expressly approved by Lessor, Lessor may, at any time during the term of this Lease, require that Lessee remove any part or all of the same.

  • Statewide special election means a special election called by the governor or the

  • Standard Installation means the installation of drop cable to a customer’s premise where the distance from the point of entry into the building being served is less than 150 feet from the active cable television system plant.

  • Regulatory Flood Protection Elevation means the “Base Flood Elevation” plus the “Freeboard”. In “Special Flood Hazard Areas” where Base Flood Elevations (BFEs) have been determined, this elevation shall be the BFE plus two (2) feet of freeboard. In “Special Flood Hazard Areas” where no BFE has been established, this elevation shall be at least two (2) feet above the highest adjacent grade.

  • Permanent radiographic installation means an enclosed shielded room, cell, or vault, not located at a temporary jobsite, in which radiography is performed.

  • Military installation means: a base, camp, post, station, yard, center, homeport facility for any ship, or other activity under the jurisdiction of the Department of Defense, including any leased facility, which is located within any of the several States, the District of Columbia, the Commonwealth of Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, the Northern Marianas Islands and any other U.S. Territory. Such term does not include any facility used primarily for civil works, rivers and harbors projects, or flood control projects.

  • Automatic tabulating equipment means apparatus that automatically examines

  • Loose-fitting facepiece means a respiratory inlet covering that is designed to form a partial seal with the face.

  • Additional Equipment means equipment that is not factory fitted in the Vehicle, including but not limited to navigation equipment (GPS), baby seat, bicycle rack etcetera;

  • Installation inspector means a person who, by reason of his knowledge of the physical sciences and the principles of engineering, acquired by a professional education and related practical experience, is qualified to supervise the installation of tank systems.

  • Specialty Alterations means Alterations consisting of kitchens, executive bathrooms, raised computer floors, computer installations, vaults, libraries, internal staircases, dumbwaiters, pneumatic tubes, vertical and horizontal transportation systems, and other Alterations of a similar character.

  • Certificate of Substantial Completion means the certificate executed by the A/E, ODR and Contractor that documents to the best of A/E’s and ODR’s knowledge and understanding, Contractor’s sufficient completion of the work in accordance with the Contract, so as to be operational and fit for the use intended.