Agilent Technologies's Enterprise Edition 1.60 is now its standard platform for instrument qualification in regulated laboratories, and is the only service available with new chromatography systems
Agilent's Enterprise Edition was introduced in 2006 as a flexible, automated, convenient and paperless way to comply with laboratory regulations worldwide.
The service covers all major laboratory instruments, regardless of manufacturer.
Enterprise Edition, which reduces qualification report review and approval time by as much as 66 percent compared with manual methods, has achieved worldwide popularity as the approved choice for chromatography equipment qualification.
"Enterprise Edition is fully established in many of the world's top life science labs, including those of major regulatory and standards organisations," notes Laura Hammond, marketing manager for the Agilent services and support division.
"Making this our compliance platform for all new Agilent instruments assures that our customers receive the latest product enhancements to meet changing regulatory requirements and reduce the business risk of non-compliance".
The newly released Enterprise Edition 1.60 makes compliance even more efficient and less costly for pharmaceutical companies and others in regulated environments.
Version 1.60 offers streamlined service delivery to minimise the amount of time systems are kept out of operation during qualifications; major usability and automation upgrades that improve workflow; and expanded flexibility for users to configure testing parameters across a wider operational range to cover all the analyses they perform.
"Our customers tell us their routine methods use parameters that fall outside of current commercial operational qualification testing ranges," explains Paul Coombes, Agilent's worldwide compliance programme manager.
"So we've made it possible for them to easily select user-specified testing and parameters to cover all their analytical methods".
Enterprise Edition's Agilent Compliance Engine software automates the compliance process for secure, automated testing, results calculation and reporting in a format that most regulatory agencies recommend.
This assures adherence to qualification protocols and avoids human errors that can lead to regulatory citations.
Other benefits include one single testing protocol across the whole laboratory and between various laboratories, spanning different instrument makers.
This provides consistency and comparability in validation results.
Searchable, electronically signed reports eliminate the need for bulky data storage and facilitate data retrieval during audits.
Agilent will no longer offer Classic Edition OQ/PV for newly purchased standard chromatography systems, but will continue to support Classic Edition contracts for existing customers.
