Synbiosis™ ProtoCOL 3 Instrument Validation Procedures

ProtoCOL 3 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.

Catalog Number	Mfr. No.	Service Offering
01-257-323	Synbiosis™ OQPR3	Operational Qualification
01-257-324	Synbiosis™ IQOQPR3	Installation and Operational Qualification
01-257-325	Synbiosis™ IQOQPQPR3	Installation, Operational, and Performance Qualification

Description

• 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.

Specifications

• For Use With (Application): Instrument Validation