In FDA guidelines 21CFR-11 compliancy is mandatory for almost all software controlled instruments. Spark Holland is one of the first companies that integrated her Reliance autosampler in the recently released Analyst 1.4.1. using the brand new AAO interface. It enables the user to control the Reliance with the Analyst software and be fully 21CFR-11 Compliant.
The AAO interface allows the Reliance control software to:
Fully control the Reliance from Analyst
Store its protocols as part of the acquisition methods of Analyst
Offer the same import and export features using native Analyst batch files
Derive the same security settings as used in Analyst
Facilitate Electronic Signatures and Audit trails via Analyst
Offer the same ease of use e.g. intuitive check boxes will activate or inactivate certain features by a click of a button.
Ready for the future
The Reliance autosampler is designed for the high throughput bio-analytical LC-MS/MS labs. Facilitating up to 24 well plates in a conditioned environment it enables long unattended reproducible runs.
With as little as 1-2 recommended preventive maintenances a year, downtime is reduced to an absolute minimum. The robustness of the Reliance originates from its simple and effective design which has been tested for 1.6 Million injections. The Reliance autosampler can be integrated in Spark’s fully automated Symbiosis Pharma System. As a complete front-end solution for the Mass-spectrometer it will perform virtually any task: common LC, XLC integrated sample clean-up, Advanced Method Development, by a click of a button without reconfiguration or re-plumbing. The Symbiosis Pharma Control Software for Analyst 1.4.1 enables 21CFR-11 compliancy via the AAO interface. Integrated in the Symbiosis System or operating as a Stand Alone unit the Reliance autosampler will be a leap forward for the high throughput bio-analytical LC-MS/MS lab.
