Qualification/Compliance Services

Empower SystemsQT for Instruments

Empower SystemsQT Qualification Tool (SQT) is built right into your Empower Chromatoghraphy 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.

Using SystemQT

Using SystemsQT instead of other options addresses a number of concerns that have become a key focus of regulators including the need for original records (21 CFR 211.180), and complete records (21 CFR 194) of the periodic calibration of laboratory instruments required by 21CFR 211.160. Qualification services that give you only printed results without access to all the meta data do not meet these requirements and leave you at risk of failing an audit. Further, many of these qualification services also do not demonstrate the ability of your system to function properly with your Chromatography Data System (CDS) of record. Empower SystemsQT gives you easy access to all your qualification results, demonstrates instrument and data system compatibility. It is Part 11/Annex11 ready with electronic approval capability for those moving their laboratory to paperless operation.

Qualification/Calibration Chemistry Kits

These  kits are employed in conjunction with Empower SystemsQT and Qualification Workbooks. They include specially-prepared solutions that can be used directly or diluted according to qualification instructions. Each calibration kit comes with a Certificate of Analysis.

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Qualification Training

We offer courses to train your personnel to perform laboratory system qualification and software qualification using Waters Empower SystemsQT or traditional qualification workbooks. 

For information about Empower SystemsQT courses, please contact your local Waters representative. 

Additionally, Waters offers classroom and web-based courses that increase your knowledge on applications, theory of operation, software use, and maintenance procedures for your laboratory systems.