Regulatory compliance can be a minefield, so having experienced support at your side provides an added peace of mind. With AB SCIEX Qualification Services, trained, certified engineers will guide you through Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Re-Qualification processes as part of your overall system validation.
Benefits of AB SCIEX Qualification Services
- Enables a quick system startup – verification can be performed immediately after installation
- Reduces laboratory start-up/downtime after repairs or scheduled maintenance
- Provides unmatched experience and knowledge of our instruments and systems
- Reduces your in-house verification time and cost
- Reduces your need for in-house technical expertise
The Installation Qualification (IQ) procedures help ensure that instrumentation is delivered and installed according to AB SCIEXs’ (or OEM vendors’) documented specifications. This 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:
The IQ service, performed by a field service engineer certified by AB SCIEX , includes recorded evidence that your system meets installation and configuration specifications through the use of certified service tools, and traceable, revision-controlled test procedures. Travel and labor of the 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 other major service events by testing established conditions and known sample characteristics. To ensure the instrument's accuracy and precision, we confirm that hardware, firmware, and software revisions meet compatibility requirements (that have been tested and approved by AB SCIEX). Our engineers have unmatched experience and knowledge of our systems.
Operational Qualification (OQ) for the Triple Quad™ System includes:
Operational Qualification (OQ) for the QTRAP® System includes:
Operational Qualification (OQ) for HPLC systems – Shimadzu Prominence Series and Agilent 1100/1200 Series includes:
The Operational Qualification (OQ) service, performed by a field service engineer certified by AB SCIEX, verifies that system components meet specified performance criteria using certified service tools, traceable, revision-controlled test procedures, and certified chemical test kits.
A Performance Qualification is a recommended part of an end-to-end system qualification, that includes IQs, OQs, and CSV and provides consistent performance qualifications that are independent of an application, method, or test kit. The Performance Qualification tests and documents overall LC/MS system functionality by evaluating the gradient separation and MS/MS quantiation of a standard compound mixture. Tests prove proper connectivity, communication, and inter-operability of HPLC, MS, and data systems.
Performance Qualification (PQ) Test
For GLP labs, the PQ test 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 now provides a new validation solution for the regulated laboratory environment.