Liquid Chromatography Blog

Method transfer compliance and data integrity

Do you work in a regulated laboratory? Are you struggling with method transfer? Would you like help with your compliance and data integrity issues? If so, Thermo Fisher Scientific offers a number of resources to help.

 

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BeccyBellDelivering a collaborative approach for successful method transfers and routine quality control batch release testing
In this presentation, Beccy Bell (Broughton Laboratories) will discuss different types of method transfers and an integrated approach for transfers both in and out of the laboratory: By viewing, you will learn about the common challenges encountered during method transfers and the processes to ensure a successful transfer; the importance of acceptance criteria for delivering a smooth transition to quality control release testing; and how to implement laboratory efficient processes to deliver a premium quality control service.

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Method-TransferMethod transfer of a USP-derived acetaminophen assay from a Thermo Scientific™ UltiMate™ 3000 SD system to a Thermo Scientific™ Vanquish™ UHPLC system
Thermo Fisher Scientific offers both an application note and white paper describing how to achieve straightforward method transfer using flexible system volume adjustment, and fine tune retention times by adjusting the idle volume of the autosampler metering device.

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MetoprololMetoprolol impurity testing by charged aerosol detection: method transfer and optimization of a USP method
Thermo Fisher Scientific offers an application note that covers how to implement the new USP method for impurity analysis of the small molecule pharmaceutical metoprolol succinate on different HPLC-CAD systems. The note will describe illustrate replication of the monograph method on an older model of CAD – Thermo Scientific™ Dionex™ Corona™ ultra RS™ CAD, and how easily the method is transferred to newer generation systems such as the Corona Veo/Vanquish CAD. Both detectors easily satisfy the resolution and peak area reproducibility requirements for system suitability specified in the compendial method.

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eBook-imageThermo Scientific Enterprise Software Solutions for Compliance and Data Integrity
Data integrity is a fundamental element of ensuring compliance in a regulated laboratory and is not a new concept. However, with computerized laboratory systems now taking the place of paper systems, your compliance strategy must adapt, or you risk difficult regulatory inspections. Ensure you are delivering assurance and credibility by using a modern software system to ensure compliance. Thermo Fisher Scientific offers an eBook that includes how to comply with 21 CFR Part 11, how to achieve compliance and ensure data integrity, and how to improve performance and cost savings with "the cloud".

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