UV Validator Qualification Procedure for Spectrophotometer Systems

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1 UV Validator Qualification Procedure for Spectrophotometer Systems Validates: Evolution 300 and Evolution 600 Spectrophotometers

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: World Wide Web: For International Support, please contact: Thermo Fisher Scientific Telephone: World Wide Web: Trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries , Rev A ii Qualification Procedure for Spectrophotometer Systems

3 Contents Introduction...1 Test Plan Overview...2 Testing Requirements...3 Test Procedures...4 EP1 Safety...4 EP2 Unit location...4 EP3 Additional systems...4 EP4 PC only instrument power up...5 Appendix A Installation Sheet...7 Appendix B Test Result Sheet...8 Qualification Procedure for Spectrophotometer Systems iii

4 This page intentionally left blank. iv Qualification Procedure for Spectrophotometer Systems

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) of the instrument as received. Qualification Procedure for Spectrophotometer Systems 1

6 Test Plan Overview Each procedure should be performed and the accompanying sheets (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 Sheet 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 log book. 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 instrument dependent and should be cleared by pressing OK, and does NOT constitute a fail for the test. 2 Qualification Procedure for Spectrophotometer Systems

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): Site and Safety Information manual. User Guide. Qualification Procedure for Spectrophotometer Systems 3

8 Test Procedures EP1 Safety EP2 Unit location Read the safety instructions in the Site and Safety Information manual. If these instructions have been read and understood, then this test is passed. Position the spectrophotometer in a suitable environment. (Environmental requirements are listed in the Site and Safety Information manual.) Verify that the correct line voltage is available, and can be connected by a suitable power cord, as per the instructions in the Site and Safety Information manual. Notice Do not turn on the power to the spectrophotometer. If the spectrophotometer has been placed in a suitable location and the appropriate power is ready to be applied to the instrument, then this test is passed. EP3 Additional items Any accessories, PC and/or external printer should be installed after the IQ/OQ for the instrument has been completed. Compliance with the appropriate instructions, resulting in configured units adjacent to the spectrophotometer is considered a pass to this test. Note If the installation consists solely of a Local Control instrument with no additional system components, circle on the Test results sheet. 4 Qualification Procedure for Spectrophotometer Systems

9 EP4 Instrument power up For Local Control models, follow the power up test procedures detailed in the Local Control OQ documentation and circle on the Test Results Sheet. Complete the Local Control OQ plan to finish the qualification of the instrument. For PC-only models, apply power to the spectrophotometer. The LED light (lower right-hand corner of the instrument) indicating applied power lights up. Lighting of the LED light constitutes a pass to this test. Proceed to the Software OQ Plan to finish the qualification of the instrument Qualification Procedure for Spectrophotometer Systems 5

10 6 Qualification Procedure for Spectrophotometer Systems This page intentionally left blank.

11 Appendix A Installation Sheet System: Customer generated number for the complete system. Validator: Version number(s) of the Manual (Validator log book) Instrument model number: Instrument serial number: Local Control software version number: Instrument firmware application software version number: Instrument firmware boot software version number: Other details: Other equipment used (model, serial no., calibration date, software version, simulators, etc.): Tester signature: Print name: Witness signature*: Tester initials: Date: Date: Print name: Qualification Procedure for Spectrophotometer Systems 7

12 Appendix B Test Result Sheet Sheet _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 EP1 Date: Date: Date: EP2 Date: Date: Date: EP3 Date: Date: Date: EP4 Date: Date: Date: Tester signature: Print name: Witness signature*: Tester initials: Date: Date: Print name: 8 Qualification Procedure for Spectrophotometer Systems

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