R E L E A S E N O T E S SystemsQT for Waters Alliance HPLC Systems (Revision G) Waters has rereleased the Systems Qualification Tool (SystemsQT ) for Alliance HPLC Systems. These release notes detail the new PDF documents, revised PDF documents, and deleted PDF documents of the Alliance SystemsQT Projects/Documentation DVD (part number 667003309, Revision G). The DVD files are arranged in appropriately named folders. These folders permit browsing, to locate applicable documents, projects, and example reports, which are provided by test name instead of configuration. Unsupported configurations This Systems Qualification Tool does not support 2795 Alliance HT systems that include a 410, 2410, or 2414 detector. New projects English-language projects SQT_E_W2690_5_W2475 SQT_E_W2690_5_W2487 SQT_E_W2690_5_W2489 SQT_E_W2690_5_W2996 SQT_E_W2690_5_W2998 SQT_E_W2690_5_W410 SQT_E_W2790_5_W2475 SQT_E_W2790_5_W2487 SQT_E_W2790_5_W2489 SQT_E_W2790_5_W2996 SQT_E_W2790_5_W2998 SQT_E_W2790_5_W410 Alliance and Waters are registered trademarks and Empower, SystemsQT, and THE SCIENCE OF WHAT S POSSIBLE. are trademarks of Waters Corporation. All other trademarks are the sole property of their respective owners. Copyright 2011 Waters Corporation June 2011 *716003455* *Rev.A* Page 1 of 6
New PDF document Test Descriptions and Specifications of SystemsQT for 2695 Alliance/2795 Alliance HT Systems with a 2475 Detector (part number 715003133, Revision A) Revised PDF documents with a 2475 Multi λ Fluorescence Detector (part number 715001912, Revision B): On page 1, the vial positions and sample concentrations table is updated. with a 2414, 2410, or 410 RI Detector (part number 715001913, Revision B): On page 1, the vial positions and sample concentrations table is updated. with a UV/Vis Detector (part number 715001914, Revision B): The document is updated to include sample management for the 2795 Alliance HT system. On page 1, the vial positions and sample concentrations table is updated. Operational Qualification Procedure for 2695/2795 with 2475 Flow Rate Accuracy, Manual Wavelength Calibration, Emission Units Normalization, and Raman Signal-to-Noise Tests (part number 715001871, Revision B): Form 11 is revised to provide a location and record the result of the manual wavelength calibration test only. The Flow Rate Accuracy Test, Emission Units Normalization Test, and the Raman Signal-to-Noise Test sections are revised to refer to recording test results in Empower software. The Recording the test results and printing the report section is Operational Qualification Procedure for the 2695 Sample Heater/Cooler, Column Heater, Column Heater/Cooler, and Bar Code Reader (part number 715001872, Revision B): Form 5 is revised to provide locations to record results of the bar code reader test only. The Testing the sample heater/cooler temperature accuracy section is revised, to test two set point temperatures. The section also refers to recording test results in Empower software. Page 2 of 6
The Testing the first-generation column heater temperature accuracy section and the Testing the second-generation column heater or column heater/cooler temperature accuracy section are revised to refer to recording test results in Empower software. The Recording the test results and printing the report section is Operational Qualification Procedure for the 2795 Sample Heater/Cooler, Column Heater, Column Heater/Cooler, and Bar Code Reader (part number 715001873, Revision B): Form 6 is revised to provide locations to record results of the bar code reader test only. The Testing the sample heater/cooler temperature accuracy section is revised, to test two set point temperatures. The section also refers to recording test results in Empower software. The Testing the first-generation column heater temperature accuracy section and the Testing the second-generation column heater or column heater/cooler temperature accuracy section are revised to refer to recording test results in Empower software. The Recording the test results and printing the report section is Operational Qualification of the Waters 3100 Mass Detector: Manual Tests Performed Before Automated Tests (part number 715001884, Revision C): On page 2 of Form 13, the requirement to log the Installed Sample Loop Size is deleted. Test Descriptions and Specifications of SystemsQT for 2695 Alliance/2795 Alliance HT Systems with a 2414/2410/410 Detector (part number 715001653, Revision B): The document is updated to also apply to Empower 3 software. The test descriptions and specifications for the 2695 Alliance and 2795 Alliance HT systems with a 2475 detector are moved to a new document: Test Descriptions and Specifications of SystemsQT for 2695 Alliance and 2795 Alliance HT Systems with a 2475 Detector (part number 715003133, Revision A). The document is revised to only include test descriptions and specifications for the 2695 Alliance and 2795 Alliance HT systems with 2414/2410/410 detectors. Test descriptions for Sample heater/cooler temperature accuracy test, the Firstgeneration column heater temperature accuracy test, and the Second-generation column heater or column heater/cooler temperature accuracy test are The test descriptions for Test injections, Wavelength accuracy test, Detector sensitivity test, and Detector linearity test are updated. The test descriptions and specifications for Carryover test and Noise and drift test are All Determining pass/fail criteria sections are updated to state the need for checking the chromatographic results table to ensure all peaks are found. Page 3 of 6
The Automated OQ test specifications section is updated to provide a separate specifications table for the 2695 and the 2795 separations module. Test Descriptions and Specifications of SystemsQT for 2695 Alliance/2795 Alliance HT Systems with a 2487/2489/996/2996/2998 Detector (part number 715001565, Revision D): The document is updated, to also apply to Empower 3 software. Test descriptions for Sample heater/cooler temperature accuracy test, the Firstgeneration column heater temperature accuracy test, and the Second-generation column heater or column heater/cooler temperature accuracy test are The test descriptions for Test injections, System precision test, Wavelength accuracy test, and Detector linearity and sensitivity test are updated. The test descriptions and specifications for the Detector noise and drift test are All Determining pass/fail criteria sections are updated to state the need for checking the chromatographic results table, to ensure all peaks are found. In the Automated OQ test specifications tables, the specification for height is added to Test injections and System precision, and the sensitivity specification for 2487/2489 detector linearity and sensitivity and 996/2996/2998 detector linearity and sensitivity is updated. 2795 Alliance HT System with a 2475 Detector (part number 715001919, Revision B) The document is updated for the 2795 Alliance HT system. The document is updated to specify the XBridge C18 column, 4.6 50 mm, 3.5 mm, part number 186003031. The Startup Procedure section is updated to disable the Alliance or Alliance HT stop on column heater fault function. The 2695 ealliance and 2795 ealliance HT System Priming and Equilibration section is The 2695 Alliance and 2795 Alliance HT System Priming and Equilibration section is updated to include the steps for priming and equilibrating. Sections describing the auto-prime methods are deleted. 2795 Alliance HT System with a 2414/2410/410 Detector (part number 715001920, Revision B) The document is updated to include the 2795 Alliance HT system. In the Startup Procedure section, step 2 is updated to indicate the internal temperature of the detector. Page 4 of 6
The Startup Procedure section is updated to disable the Alliance or Alliance HT stop on column heater fault function. The 2695 ealliance and 2795 ealliance HT System Priming and Equilibration section is The 2695 Alliance and 2795 Alliance HT System Priming and Equilibration section is updated to include the steps for priming and equilibrating. Sections describing the auto-prime methods are deleted. 2795 Alliance HT System with 2487/2489/996/2996/2998 Detectors (part number 715001921, Revision B) The document is updated to include the 2795 Alliance HT system. The Startup Procedure section is updated to disable the Alliance or Alliance HT stop on column heater fault function. The 2695 ealliance and 2795 ealliance HT System Priming and Equilibration section is The 2695 Alliance and 2795 Alliance HT System Priming and Equilibration section is updated, to include the steps for priming and equilibrating. Sections describing the auto-prime methods are deleted. Protocol, Waters Systems Qualification Tool (SystemsQT) (part number 715001511, Revision F) In the Installing the SystemsQT section on page 1, the section is updated to include the activation license. In the Supported operating systems section on page 3, the section is updated to include Empower 3. In the Setting up the SystemsQT for a regulated environment on page 4, step 2 is updated to specify that the account must have privileges to restore a project. In the Running the Waters SystemsQT section, step 27 on page 14, is added to describe printing the SystemsQT summary report on Alliance and Alliance HT systems. Deleted PDF documents The Alliance SystemsQT Projects/Documentation DVD no longer includes maintenance reference information. That information now appears on the DVD in PDFs of instrument or system operator s guides. Waters SystemsQT Sample Management for the 2795 Alliance HT System with a UV/Vis Detector (part number 715001915, Revision A) This PDF document is deleted, its content now combined with that of the revised document with a UV/Vis Detector (part number 715001914, Revision B) Page 5 of 6
SystemsQT Instrument and System Qualification Setup Procedure for the 2795 Alliance HT System with 2487/2489/996/2996/2998 Detectors (part number 715001922, Revision A) This PDF document is deleted, its content now combined with that of revised document 2795 Alliance HT System with 2487/2489/996/2996/2998 Detectors (part number 715001921, Revision B) Page 6 of 6