Empower SystemsQT for Instruments
Empower SystemsQT Qualification Tool (SQT) is built right into your Empower Chromatography Data System (CDS) and uses a patented process to qualify systems in the way they will be used. It can manage Installation Qualification (IQ), Operational Qualification (OQ), and system level performance testing on the following systems:
Waters ACQUITY UPLC Systems
Waters PATROL UPLC Analyzer
Waters Alliance HPLC Systems
Waters Arc Systems
Waters e-SAT/In Module
Waters ACQUITY UPC2 System
Agilent 1260 HPLC systems and 1290 UHPLC systems
Agilent 7890 GC systems
Empower SystemsQT the best option to qualify your LC and GC systems
We qualify your instruments and your Empower CDS as a complete system by performing chromatography in a similar manner to how you will use your system on a routine basis.
SystemsQT Provides Accurate Qualification Testing and Analysis.
Comply with 21 CFR 211.68 and 211.160 predicate rules
Less opportunity for human error
Measures peak areas, peak heights and retention times accurately and consistently
Custom field calculations and regression analysis
Testing consistent from system to system and across worldwide sites
Reduces time that system is off-line for qualification by about half
Multiple systems can be qualified at once reducing laboratory down time even further
Qualifies software and systems in their analytical configuration
Qualifies using same peak processing and quantitation algorithms used on CDS system of record
Demonstrates system level fitness for chromatographic use
You Get Secure and Audit Ready Qualification Data:
21 CFR Part 11 Compliant Ready Qualification Data
Original Data is maintained on your CDS (comply with 21 CFR 211.180)
Complete Data is available for review and approval (comply with 21CFR 211.194)
On-Line Qualification Documentation for easy inspection
Audit Trails and method change control are part of the data system
No need for external spreadsheets or third party software
Easy tracking and trending of qualification results
Secure data environment
On-line review and approval available
Empower SystemsQT for Software
According to United States Food and Drug Administration predicate rules for CGMP, Title 21 CFR 211.68, computer systems used in the testing of regulated products need to be verified routinely in order to assure proper performance. Empower SystemsQT Qualification Tool for software is designed to provide documented evidence that the proper files have been installed and have not been altered or corrupted. The tool also demonstrates computational accuracy of the computer hardware as well as report generation. This testing is not designed to replace comprehensive computer software validation specific to your intended use but rather demonstrates the ability of your Empower Chromatography Data System to provide consistent results at installation as well as after continued use.
Qualification for UNIFI Based Systems
UNIFI Scientific Information System features the UNIFI Qualification Center. Expanding on the functionality of Empower SystemsQT as outlined above, UNIFI adds a unique workspace called the Qualification Center that provides the ability to run, store, manage, and approve your qualification data. Automated and manual methods can be run, processed, and then documented in one central location.
The qualification center allows you to check on the qualification status of any system on the UNIFI network using quick visual indicators so you can better manage qualification activities for your instrumentation.
Additionally, Maintenance Log capabilities are also built into and accessible in the Qualification Center so you can track when maintenance is due and log any work performed on any instrument quickly and easily. Information relating to Performance Maintenance of the modules in your system is also accessible right in the Qualification Center saving you time and making your job easier.
Qualification for MassLynx Based Systems
Workbooks created specifically to qualify MS and LC-MS Systems are intended to be used by Waters trained and qualified Compliance Specialists. Test solutions and mobile phase additives with certificates of analysis are provided as part of the service.
Qualification using Traditional Qualification Workbooks
Traditional Waters Qualification Workbooks (QWBs) provide the ability to qualify Waters HPLC systems using step by step procedures along with pre-defined limits based on instrument specifications. Designed for purpose test solution kits with certificates of analysis make the process easier and provide traceability where needed. The procedures in these workbooks can be carried out either by Waters trained and certified Compliance Specialists or by your own internal resources. Waters offers training courses in their use.