Agilent Technologies Inc.

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This company has just introduced an updated version of its ChemStation Plus chromatography data system, designed to help users validating analytical methods according to the regulations of the pharmaceutical industry. The new package is said to be the first system of its kind to provide solution stability calculations for short- and long-term stability studies as defined by the International Conference for Harmonization (ICH). The software further offers major productivity improvements for validation planning, execution and reporting.

The method validation pack features advanced statistical calculations and result management in a relational database, and integrates seamlessly with the ChemStation Plus CDS. It is the only pharmaceutical software available that supports automated method validation from planning to final reporting according to ICH, Pharmacopoeia and FDA guidelines, including 21 CFR Part 11.Version A.02.01 supports stability testing of drugs over the short term (24 to 72 hours) and long term (12 to 24 months) according to ICH Q1A and Q2B guidelines.

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