Qualification

The Installation Qualification (IQ) procedures help ensure that instrumentation is delivered and installed according to AB SCIEXs' (or OEM vendors') documented specifications. The service documents the completeness of shipping and components of the system. Additionally, the IQ verifies and documents that all materials shipped were received or that upgrades are compatible with the system configuration.

Installation Qualification (IQ) Procedure

 AB SCIEX engineers have unmatched experience and knowledge of our instruments and systems. Every comprehensive IQ service we perform includes the following:

• Order and System Verification to verify that the instrumentation ordered was received and fully documented
• Documentation Verification to verify documentation is recorded
• Installation Verification to verify the installation meets specification
• Software Identification Verification to document current versions and verify compatibility
• Maintenance Verification to verify that SOPs for maintenance exists
• Customer Training Verification to verify customers are trained on the basic operation and use per AB SCIEXs' specifications
• Certifications for test equipment and field service engineer
•  Record that instrument is installed in a suitable environment for operation
• Verification of hardware to verify it functions according to AB SCIEXs' specifications upon installation

The IQ service is performed by an AB SCIEX certified field service engineer and includes recorded evidence that the system meets installation and configuration specifications using certified service tools, traceable and revision controlled test procedures. Travel and labor of the AB SCIEX field service engineer is also included.

The Operational Qualification (OQ) Service verifies and records the instrument's ability to meet specified performance criteria after installation, repetitive use, or major service events and uses comprehensive testing with established conditions and known sample characteristics. We help confirm that the instrument hardware, firmware, and software revisions meet AB SCIEX tested and approved compatibility requirements ensuring the accuracy and precision of the instrument. Our engineers have unmatched experience and knowledge of our instruments and systems.

Operational Qualification (OQ) for Triple Quadrupole Instruments includes:

• Quadrupole-mode operation for sensitivity, resolution, and extended mass range resolution in both positive and negative ion  modes. Note that the masses tested for each instrument are based on the mass range specification for the instrument.
• Tandem MS mode (MS/MS) for sensitivity
• Ion source purchased with the system (plus optional specified sources)

Operational Qualification (OQ) for QTRAP System Instruments includes:

• Quadrupole-mode operation for sensitivity, resolution, and extended mass range resolution in both positive and negative ion modes.  Note that the masses tested for each instrument are based on the mass range specification for the instrument.
• Tandem MS mode (MS/MS) for sensitivity
• Ion source purchased with the system (plus optional specified sources)
• Linear Ion Trap functionality testing for sensitivity and resolution at all scan speeds in negative and positive polarities

1. 250 amu/sec scan speed
2. 1000 amu/sec scan speed
3. 4000 amu/sec scan speed

• MS/MS/MS Trap functionality in positive mode

Operational Qualification (OQ) for HPLC - Shimadzu Prominence Series and Agilent 1100/1200 Series includes:

• Pump flow reproducibility/accuracy test
• Autosampler linearity test
• Autosampler carryover test
• Autosampler temperature accuracy test
• UV detector wavelength accuracy test
• UV detector noise and drift test
• UV detector linearity test
• Pump gradient composition test
• Thermostatted column compartment temperature accuracy test
• LC/MS/MS system performance verification linearity and precision test

The Operational Qualification (OQ) service is performed by an AB SCIEX certified field service engineer and includes recorded evidence that the system components meet specified performance criteria using certified service tools, traceable and revision controlled test procedures, and certified chemical test kits.

Performance Qualification (PQ) Test

• Holistic test of overall LC/MS system performance
• Tests meet regulatory and commonly-specified internal requirements for PQ in regulated laboratories
• Performed by factory trained, certified AB SCIEX engineers
• Available for AB SCIEX Triple Quadrupole and QTRAP Mass Spectrometers with Agilent 1200, 1260*, 1290 Shimadzu LC-20 (Prominence), LC-30* (Nexera) systems
• Also appropriate for non-regulated environments to ensure analytical system operation to vendor specifications

For GLP labs the PQ provides a single, well documented Performance Qualification (PQ), standardized across your instrument and assay portfolio, which bridges the gap between Operational Qualification and system suitability. For non GLP labs with non qualified LC-MS systems, the Performance Qualification (PQ) standardizes your instrument and assay portfolio, providing an independent verification of the LC-MS system functionality.

With the addition of Performance Qualification (PQ) to our comprehensive Compliance portfolio, AB SCIEX can provide a new validation solution for the regulated laboratory environment.

* LC/MS PQ for the Agilent 1260 and Shimadzu LC-30 will be available summer 2011

Brochures

Installation Qualification (IQ) Service for AB SCIEX Instruments

Re-Qualification-OQ/IPV Services for AB SCIEX Triple Quadrupole Mass Spectrometers

Re-Qualification-OQ/IPV Services for AB SCIEX  QTRAP^® Hybrid Triple Quadrupole/Linear Ion Trap Mass Spectrometers

Re-Qualification-OQ/IPV Services for AB SCIEX QSTAR^® Hybrid LC/MS/MS Systems

Re-Qualification-OQ/IPV Service for Agilent HPLC Systems

Re-Qualification-OQ/IPV Service for Shimadzu Series HPLC Systems

Performance Qualification (PQ) Service for AB SCIEX Instruments