Qualification

In response to market trends, Jaytee have developed a series of procedures for laboratories that have a requirement for HPLC instrument qualification or performance qualification (PQ).

At Jaytee, we are aware of the vast array of different levels and criteria tested by PQ and have adopted a unique system to ensure that all labs can meet, with confidence, the criteria required by the various regulatory bodies.

HPLC qualification versus PQ

Jaytee have evolved a complete system of instrument HPLC & GC qualification. Our methods differ in some ways from our competitors and offer the customer a much more comprehensive service.

No more problems of deciding what to do if your instruments initially fails qualification:

Jaytee offer HPLC & GC qualification in preference to PQ. Our agreements ensure your instrument is compliant since we can repair and re-qualify your instruments if at first they fail the qualification process.

Four stages for Compliance

Jaytee’s approach to qualification is divided into four stages. Each stage allows you to achieve your goals, without the need to set up your own elaborate systems and procedures.

Consultation – Deciding your qualification strategy and the tests that you require.
Adaptation – Forming a set of procedures from the information gained from the consultation stage.
Implementation – Using the unique combination of procudures to generate the required documentation and start the qualification process.
Review – At regular intervals we review the qualification procedures with our customers to ensure that the methods are updated to the latest specifications.

The Agreement

Consultation stage is free of charge
Analyse current checks that are performed
Qualification schedules are drawn up, along with testing agreement
Quotation provided for qualification agreement
Quote accepted
Adapt and implement the “Four stages for Compliance”

This whole process is designed to reduce the cost burden of implementing successful qualification. Our aim is to provide quality qualification procedures at a competitive price.

The need for documentation

Jaytee are very aware that the quality of all documentation, from procedures to certificates and raw data forms, must be of the highest standards. We ensure that all documentation is controlled and signed off at the time of the qualification. Qualification data is completed on-site, allowing immediate certification of your equipment, thus keeping instrument down time to an absolute minimum.

Qualification Certificates

The qualification certificates that we provide our customers are very simple but comprehensive documents that are based on validated spreadsheets. Our certificates are customer specific, but are based on a collection of standard certificates linked together.

Full Data Audit Trail

Supplied with the qualification certificates is a collection of completed standard forms that are used to record the results. Also included is the original raw data which is labelled and filed with the HPLC & GC qualification certificates.