USER PERFORMED QUALIFICATION

Empower SystemsQT

The same advanced technologies employed by our Compliance Services Specialists are now available for self-directed systemsQT. Streamline the qualification of:

Empower Software

Waters ACQUITY UPLC Systems

Waters PATROL UPLC Analyzer

Waters Alliance HPLC Systems

Waters Arc Systems

Waters e-SAT/In Module

Agilent 1260 HPLC systems

Agilent 7890 GC systems

 

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.

 

Validated as Part of Your Empower Installation

Empower SystemsQT is an Empower software option and as such can be validated as part of your Empower installation. It employs system level testing using the chromatography data system of record (Empower) to acquire, process and report the results, minimizing potential traceability and transcription errors.

By utilizing Empower Software's ability to run multiple systems at once, Empower SystemsQT can reduce your laboratory's downtime with its patented system level testing approach.

 

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.