Agilent Technologies introduces industry-first features in pharmaceutical method validation software

Software offers solution stability calculations for short- and long-term studies

PALO ALTO, Calif., Sept. 1, 2004

Agilent Technologies Inc. (NYSE: A) today announced the latest version of its software for validating analytical methods according to the regulations of the pharmaceutical industry. The new method validation pack version A.02.01 for Agilentís ChemStation Plus chromatography data system (CDS) is 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 is a software module that 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. 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.

Other improvements in the method validation pack include:

  • Enhanced handling of selectivity data as calculated by ChemStation
  • Submission of user-defined custom validation sequences
  • Improved reporting features, including a new summary report and customizable, color-coded report layouts
  • Export of validation reports in Adobe(r) Acrobat(r) PDF format
  • Ability to unlock review-only validations by applying an electronic signature

The ChemStation Plus method validation pack is compatible with Microsoft(r) Windows(r) 2000 and XP Professional.

Availability

Agilent ChemStation Plus data systems are available worldwide and can be ordered through any Agilent sales office. Prices vary depending on the network requirements of the laboratory, the number of users, and the number of instruments to be controlled. The newest revision of the method validation pack is available free to all customers with a valid software update contract.


About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is a global technology leader in communications, electronics, life sciences and chemical analysis. The company's 28,000 employees serve customers in more than 110 countries. Agilent had net revenue of $6.1 billion in fiscal year 2003. Information about Agilent is available on the Web at www.agilent.com.

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Contact:

Christina Maehr
+1 408 553 7205
christina_maehr@agilent.com