1. Creation of Experimental Designs relevent to the task in hand and in accordance with ICH, FDA, USP, or Ph. Eur. guidlines;
2. File-less data exchange with leading chromatography data systems, automatically transforming these designs into "ready to run sequences";
3. File-less data exchange to extract result data from chromatograms without any requirement for transcription and therefore transcription checks;
4. Automatic result collation, calculation, suitability checking, and reporting, all with a "21 CFR p11 ready" compliant environment.

Inhaler Testing

 

Inhalation device testing requires the generation of significant quantities of data that typically requires transcription across multiple applications. These transcriptions are a significant overhead in a regulated environment.

Fusion Inhaler Testing automates the flow of this data to and from LC data systems and compiles the finished reports in accordance with USP 601 and/or Ph. Eur. 2.9.18

LC Method Validation

Before any analytical method can be deemed fit for purpose within a regulated environment, extensive method validation activities are required.

Fusion Method Validation offers time savings of up to 80%, utilising the core Fusion features of LC data system integration, and automatic report compliation.

LC Method Development*

The goal of any development activity is to produce an analytical method fit for purpose. This means a robust method. Fusion Method Development applies true Quality-by-Design (QbD) principles to the task of LC Method Development allowing optimisation of methods for both Mean performance and Robustness. This approach is in full accordance with ICH Q8 - Guidance for industry, Pharmaceutical Development, May 2006.

* This module is now distributed exclusively by Waters^® for use with Empower^® 2. See press release.