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  6. Synbiosis™ aCOLyte Instrument Validation Procedures

Synbiosis™ aCOLyte Instrument Validation Procedures
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Numéro de catalogue. 01257340
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Service Offering:
Installation, Operational, and Performance Qualification
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Numéro de catalogue. Service Offering
01257340 Installation, Operational, and Performance Qualification
01257339 -
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Numéro de catalogue. 01257340 Fournisseur Synbiosis™ Code fournisseur IQOQPQAC
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Description

aCOLyte Instrument Validation Procedures take the user through each step in the verification of a Synbiosis™ system regulatory compliances and standard operational procedures (SOP). These simple procedures allow the user to verify that a system meets defined installation, operational, and performance quality specifications.

  • Installation Qualification (IQ): Verifies that when a system is unpacked it conforms with all purchasing, shipping, and unpacking documents. Once this procedure has been followed the system is then ready for the operational check process.
  • Operational Qualification (OQ): Establishes if the system meets all the operation and functionality specifications. An operational test is also included at this stage.
  • Performance Qualification (PQ): Establishes if the system meets the specification for the nature of the purpose it was intended for. This is verified by using a simple target to establish if the system can meet performance criteria.
  • Documentation: Each set of IQ/OQ/PQ documents contains a complete set of procedures and checklists for following the verification steps. Included with each pack is a simple calibration device (target image) so that the performance of the system can be checked against the PQ requirements. Each set of documents is unique to a particular system and has to be ordered with the system itself. The document pack has full instructions for use and implementation.

Spécifications

For Use With (Equipment) aCOLyte Instruments
Service Offering Installation, Operational, and Performance Qualification
For Use With (Application) Instrument Validation