UV Validator Smart Calibration Validation Carousel IQ/OQ Plan

Transcription

1 UV Validator Smart Calibration Validation Carousel IQ/OQ Plan

2 The information in this publication is provided for reference only. All information contained in this publication is believed to be correct and complete. Thermo Fisher Scientific shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance or use of this material. All product specifications, as well as the information contained in this publication, are subject to change without notice. This publication may contain or reference information and products protected by copyrights or patents and does not convey any license under our patent rights, nor the rights of others. We do not assume any liability arising out of any infringements of patents or other rights of third parties. We make no warranty of any kind with regard to this material, including but not limited to the implied warranties of merchantability and fitness for a particular purpose. Customers are ultimately responsible for validation of their systems Thermo Fisher Scientific Inc. All rights reserved. No part of this publication may be stored in a retrieval system, transmitted, or reproduced in any way, including but not limited to photocopy, photograph, magnetic or other record, without our prior written permission. For Technical Support, please contact: Thermo Fisher Scientific 5225 Verona Road Madison, WI U.S.A. Telephone: us.techsupport.analyze@thermofisher.com World Wide Web: For International Support, please contact: Thermo Fisher Scientific Telephone: support.madison@thermofisher.com World Wide Web: All trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries , Rev A

3 Contents Introduction...1 Test Plan Overview...2 Testing Requirements...3 Test Procedures...4 CVC1 Unit installation...4 CVC2 Unit operation Local Control...4 CVC3 Unit operation VISION...4 Appendix A: Test Result Sheet...7

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5 Introduction The processes detailed below form an essential part of any System Validation. These documents and structure are based on the requirements of the UK Pharmaceutical Industry Computer Systems Validation Forum (PICSVF). These guidelines were published in their document "Pharmaceutical Industry Supplier Guidance - Validation of Automated Systems in Pharmaceutical Manufacture", and have now been formally adopted as the GAMP Guidelines. This document describes the tests required for the specific Installation Qualification (IQ) and Operational Qualification (OQ) of the accessory. Smart Calibration Validation Carousel IQ/OQ Plan 1

6 Test Plan Overview Each procedure should be performed and the accompanying sheet(s) (see Appendix) must be completed and inserted into the UV Validator log book replacing any previous unused versions. The sheet(s) include spaces for signatures of the tester and a witness, where appropriate, for regulatory compliance. When you have completed and signed the sheet(s), you will have a complete record of your testing activity.. Completion of these sheets requires the following: 1. Results must be recorded on the Test Result Sheets supplied with this plan. If the result is information (e.g., computer Domain name), then enter the information in the space provided. If the result of the test is a pass, the should be circled. If the result is a failure, the should be circled. If a test is software-specific, and is not present, the should be circled ( meaning Not Applicable). 2. In the event of a test failure and corrective action taken, this should be reported on a copy of the Test Incident Sheet. A master of the Test Incident Sheet is supplied in the Template Masters section of the UV Validator CD. Once the corrective action has been taken, restart the test using the next Run column on the sheet. Any blocks not filled in (uncompleted run or 2 nd run not required) should be crossed out. Note A warning message stating that a method is not compatible with the spectrophotometer may occur, when default or demonstration files are loaded. This is spectrophotometer dependent and should be cleared by pressing OK, and does NOT constitute a fail for the test. 2 Smart Calibration Validation Carousel IQ/OQ Plan

7 Testing Requirements Testing will require the presence of two persons: one to perform the test, the other to act as a witness. To perform this System Acceptance Test, the following must be available (dependent on the system supplied): Appropriate user guides If system is to be operated using VISION: Completed and qualified installation of the software if the accessory is to be used with VISIONpro or VISIONlite. Completed installation of Security Administration for VISIONsecurity software, which requires three user accounts (profiles), one with Network Administrator rights with the ability to use all functions of the software, if required. Performance Verification and Best Practices for Performance Qualification. Smart Calibration Validation Carousel IQ/OQ Plan 3

8 Test Procedures CVC1 Unit installation Install the unit following the sequence of instructions detailed in the accessory user s guide. If the carousel can be installed as described and the calibration values stored in memory, then this constitutes a pass. CVC2 Unit operation Local Control 1. From the Main Menu page, press the Utilities function key. 2. Choose Instrument Verification from the Utilities menu and press Enter. Ensure that the instrument verification menu includes Absorbance Accuracy, UV Absorbance Accuracy and Wavelength Accuracy. 3. Highlight Absorbance Accuracy on the Instrument Verification menu and press Run. On completion of the test, verify that the Instrument No., test result, time and date are correctly reported on the instrument verification page. Problem free operation of these functions constitutes a pass to this test. CVC3 Unit operation VISION 1. Verify that the CVC icon is displayed on the VISION status bar. 2. Select Command > PV Tests. Verify that the PQ Method window now contains a PV Method tab and the list includes Wavelength accuracy, Absorbance accuracy, UV Absorbance accuracy. 3. Click in the Absorbance accuracy checkbox. 4 Smart Calibration Validation Carousel IQ/OQ Plan

9 4. Select the Run button on the PV Method page. On completion of the test, view the results window. Verify that the Instrument ID, test status, time and date are correctly reported, together with the calibration data and test results. Problem free operation of this function constitutes a pass to this test. Smart Calibration Validation Carousel IQ/OQ Plan 5

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11 Appendix A: Test Result Sheet Page_1 of _1 System (Customer generated number for the complete system): Test reference Run #1 Tester initials Run #2 Tester initials Run #3 Tester initials Accessory position Sample Reference Sample Reference Sample Reference CVC1 Date: Date: Date: CVC2 Date: Date: Date: CVC3 Date: Date: Date: Tester signature: Print name: Witness signature*: Tester initials: Date: Date: Print name: *Sign only if page(s) is/are completed. Smart Calibration Validation Carousel IQ/OQ Plan 7

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