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Operational Qualification

Operational Qualification

We offer OQ (Operational Qualification) and RQ (Re-Qualification) for your equipment as an add-on to your servicing.

The LC Services Ltd Operational Qualification (OQ) Procedures have been designed in line with good laboratory practice (GLP) and good manufacturing practices (GMP), which require that all laboratory instrumentation shall be adequately inspected, cleaned and maintained. Instruments used for generation, measurement and evaluation of data shall be adequately tested, calibrated or standardised. LC Services Ltd protocol (available on request) will define the methods and documentation that will be used to evaluate the HPLC instrument or system for operation in accordance with the intended use. Successful completion of this protocol will verify that the HPLC instrument or system is operation to your acceptance limits.

Benefits of Qualification

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To ensure the equipment performs, operates and functions as the manufacturer intended it to.

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Helping your company meet the regulatory requirements set by organizations and relevant authorities.

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Prevent faults, downtime and costly repairs as an the OQ identifies potential risks associated with the operations of the equipment.

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Provides a comprehensive report to better assist operations and future inspections to aid with the longevity of your equipment.

How does a qualification work?

Overview of Procedures

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The OQ procedures use a combination of test functions and analytical methods (using certified samples & equipment) to evaluate and verify the instrument or system is operation according to acceptable limits.

Procedures to be taken prior to Qualification

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All preventative maintenance / repairs must be completed and instrument tests carried out prior to a qualification procedure being undertaken. All standards and equipment used for qualification must be checked for compliance prior to qualification. Once all equipment has undergone initial maintenance / repair, operational qualification can be carried out in accordance with this protocol.

Preparation of Certificate

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All raw data collected is obtained using calibrated standards / equipment, which is traceable to nationally recognised standards. All chromatographic data is captured on the customer’s system and folders are generated to store the data. The OQ is performed on our very own tailor made software, generates certificates on site and is electronically signed by the engineers’ personal login.

Final Certificate

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All criteria can be tailored to the customers individual specification and the final certification is backed up to the LC Services Ltd server.

Qualification can be completely adaptable to your requirements for your equipment

We have our own software and highly trained field service engineer for your trusted qualifications.

Send us an enquiry about qualification

Get in contact with us today, and one of our team with get back to you.

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