Enables advanced integration of PA 800 Plus with Waters Empower 3 Chromatography Data Software for data integrity compliance, reducing regulatory risk and maximizing method transfer efficiency
Framingham, MA — 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
- Method Flexibility
- 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.”