SCIEX, a global leader in life science analytical technologies, announced today the launch of its much anticipated SCIEX Empower Driver version 1.3, a software interface that gives users direct control of their PA 800 Plus instrument in the Waters Empower 3 Chromatography Data System.
Biopharma quality control (QC) labs have implemented Waters Empower 3 Chromatography Data Software (CDS) to address compliance and security requirements specified in 21 CFR Part 11. Long considered the gold standard for biologic characterization, the SCIEX PA 800 Plus has been routinely interfaced to Empower using the Waters Empower Driver 1.2.1.
The new SCIEX Empower Driver v1.3 expands on the capability and flexibility of the 1.2.1 driver including validated methods for CE SDS, cIEF and glycan applications along with full system qualification through Empower. This expanded functionality increases the number of assays users can transfer to QC, allowing for greater flexibility in the implementation of QC methods, and simplifies method transfer, system validation and support.
The SCIEX Empower Driver version 1.3 offers:
Expanded CE direct control and data acquisition using Empower CDS
- PDA, UV and LIF detectors
- Normal and reverse injection status panel
- Method conversion tools
- Chemistry tested CE method templates
Data processing to include custom calculations
- Velocity Calculated Area
- Molecular weight estimate and standard curve
- pI value estimate and standard curve
- Descriptive instrument error messages to simplify troubleshooting and error log for traceability
- SCIEX Operational Qualification and Calibration Verification
“A well designed 21 CFR Part 11 compliant data management software, such as Empower, which can be used across multiple systems and system platforms, is key for laboratory compliance to electronic record keeping and data integrity regulations and can improve overall efficiency in data acquisition, analysis and archiving,” said Chantal Felten, Owner of Alpine Analytical, and regulatory and technical strategy expert for biopharmaceuticals.
“For Quality Control labs, managing data security and compliance is critical,” added Mani Krishnan, Vice President of Global Biopharma and Capillary Electrophoresis at SCIEX. “By providing our customers with the ability to interface and control the PA 800 Plus in Empower, we allow them to simplify implementation of the PA 800 Plus in QC while meeting data security and management requirements.”
SCIEX delivers solutions for the precision detection and quantification of molecules, empowering our customers to protect and advance the wellness and safety of all. We have led the field of mass spectrometry for 50 years. From the launch of the first ever commercially successful triple quadrupole in 1981, we have developed groundbreaking technologies and solutions that influence life-changing research and outcomes.
Today, as part of the Danaher family of global life science and technology innovators, we continue to pioneer robust solutions in mass spectrometry and capillary electrophoresis. Our customers are able to quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer.
That’s why thousands of life science experts around the world choose SCIEX to get the answers they can trust to better inform critical decisions that positively impact lives.
For more information, visit sciex.com.
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