Validation

Validation or verification of your instrument is an essential part of a laboratory quality system. Whether you are working in a GxP environment or under another quality system, we can provide you with the level of validation or verification you require.

“For the pharmaceutical industry, we can perform a full Installation Qualification (IQ) and Operational Qualification (OQ). Validation diagramOur engineers are manufacturer trained and authorised to carry out this work on the majority of instruments we supply. Documentation will be provided, as well as relevant certificates. All our work is carried out with traceable standards, and with calibrated equipment where relevant.

 In addition, we can provide you with information to assist in the preparation of your preliminary documentation such as User Requirement Specification (URS). Following the IQ and OQ of your instrument, your own internal procedures may require a Performance Qualification (PQ).  Although this is a user executed test, we can help you in developing an appropriate method.

 Software updates may be required during the life of your instrument. In the pharmaceutical industry, your internal procedures may require change control or validation of the upgrade. We offer two options. The software upgrade can be performed at the time of the annual OQ, prior to the OQ itself. This will give you validation of the system immediately after the software upgrade. An alternative we can provide for some instruments is a software upgrade verification (SUV). In this case, traceable standards are measured before and after upgrading the software, which provides evidence that upgrading the software has not changed the performance of the instrument.Validate IQ OQ PQ

For those outside the regulated world of pharmaceutical industry, performance verification of your instrument may still be required as part of a Quality System. The instrument performance verification provided by us is for those industries who do not require pharma level compliance. A simpler test with basic documentation, it will nonetheless provide you with the confidence that your instrument is performing correctly.” Dr. John Fleming