Validation software

Agilent Technologies has announced the latest version of its software for validating analytical methods according to the regulations of the pharmaceutical industry.

The method validation pack version A.02.01 for ChemStation Plus chromatography data system (CDS) 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.

The software offers major productivity improvements for validation planning, execution and reporting. The method validation pack is a software module that features statistical calculations and result management in a relational database and integrates with the ChemStation Plus CDS. It 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. Stability testing is routinely used to monitor how the quality of pharmaceutical ingredients and products change over time and under different environmental factors and to develop recommended storage conditions.