CLIMeES Validation: DataPro 3 software CLIMET DataPro 3 Supplemental Validation of Version 1.35 Validation Revision History Software P/N 03000071 Version 1.36 — April 1, 2015, 2014 Manual P/N 03036900 CLIMET Instruments Company Validation P/N 03036901 DatoPro 3 V1.35, Validation Aptil 1, 2015 Page | of 9 P/N 03036901CLM Validation: DataPro 3 software Required Approvals CLIMET Instruments Company. CLIMET DataPro 3, Version 1.35 Name of System Validation Initial Protocol Approval The signature below indicates approval of the methods, test procedures, and acceptance criteria defined in this protocol. Engineering Manager Final Protocol Approval All signatures indicate that the test engineer successfully completed this protocol in accordance with the methods, test procedures, and acceptance criteria defined in this protocol All signatures have reviewed and understood the data collection during the execution of this protocol. Upon the successful completion of this protocol, this system is suitable for use in commercial activities. Rencby- Gr Quality Assurance Manager DataPro 3 V1.35, Validation April 1, 2015 Page 20f 9 P/N 03036901CUM Validation: DataPro 3 software Notices Copyright © 2003-2014 by CLAMET Instruments Company. All rights reserved, Complying wih applicable coyriht laws, no part of this document ay be reproduced, sored in or intoiced to any revival ysem, | feared in any form or by fry means (leon, rechanesl, photocopying, reeling, o others), o for any purpose, without he rie turiten penusson of CLAMET Insuments Company. Contact LIME Intamentt request writen pet Ma CLIMET Instruments Company ail: Sales@CLMET com 1320 West Calton Avenue puke oie aie Redlands CA S274 Usa Fax: 900703.1738 CCLIMET instuments Company may make improvements andor changes inthe products) and/or the prosranis) described in this document at fy tne witout nie: tese nirovements anor chenge ile incorporated in ew versions ofthe documentation, Unless ofkervise noe, the example companies, organization, pods, peopl and events depict betcin ae fetious ado assoeiaion with any sel company ‘teanzaton, produc person o even tended o should be Sferred. [Although every preston hasbeen ake inthe preparation of his docimentton the author assumes no responsiblity fr techni inaccuracies typagraphiel ers, or damages resin fem the use ofthe infomation contzned Retin “The folloming paragraph does wot apply toa country where such provisions ae inconsistent with local la: CIIMET INSTRUMENTS COMPANY PROVIDES THIS DOCUMENTATION “AS IS" WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF NON-INFRINGEMENT. MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Some safes dono allow a cicsimer of express or impli ‘varanties in certtntasactios, here, hi ssement may not apply to ou, Trademarks CCLIMET isa tudematk of CLAMET insuments Company in the United States andor ther eons, Microsoft Windows, MSDE, SQL Server 2008 R2, Visual Basie NET, Visual Studios NET and Excel we twademurs of MirosoR Corporation inthe United Staves andor oer counties, VeriSign is radematk of VeriSign athe United States andr other counties, BSA and MDS are tradcorks of RSA Sesuiy Ine. Inthe United States andlor cher countries. The names of setual companies ad products mentioned herein may be the wademarks of thet respoatve owners Supplementary Features Note _ indicates notes related to the nearby text. Tip __ indicates tips related to the nearby text. Typographical Conventions Bold _ indicates important words, or names of buttons, menus, and windows. Italic indicates new terms, or terms in glossary, > indicates a procedure in the table of contents. § __ indicates reference to a section number. DataPro 3 V1.35, Validation April 1, 2015 Page 3 of 9 P/N 03036901CuMET Validation: DataPro 3 software Table of Contents 1 Introduction: 4 OQ: Operational Qualification 4.1, Scope . 4.2. User Requirements. 4.3 Functional Specifications ... 44 Traceability Matrix... 45 Text Changes 6 6 6 7 28 9 4,6 Spanish Windows 7 particle size formatting fi DataPro 3 1.35, Validation Apail 1, 2015 Page 4 of 9 P/N 03036901CuUMEs: Validation: DataPro 3 software 1 Introduction CLIMET Instruments Company designed, constructed and validated CLIMET DataPro 3 Version 1.36 at the CLIMET facility in Redlands, California. The validation method described herein is consistent with CLIMET's “SOFTWARE DEVELOPMENT, DOCUMENTATION AND. REVISION STANDARDS" policy (Revision 3.0 - 03/04/1999). The purpose of this validation document is to provide documented evidence that DataPro will correctly install and consistently operate in accordance with the procedures outlined in the DataPro manual, This protocol describes all of the conditions and tests performed for this validation, The manual describes DataPro. The validation system has inputs and outputs. The inputs to the validation system are particle samples and the DataPro user interface. The outputs of the system are printouts, databases and the data recorded in this document. 2 System Requirements & Equipment Q See requirements in DataPro 3 v1.35 manual 3 1Q: Installation Qualification 3.1 Scope The installation process provides a default installation path. 3.2 Peripherals Test Check that the following items are present 1 One DataPro installation CD DataPro 3 1.35, Validation April 1, 2015 Page Sof 9 P/N 03036901CLM Validation: DataPro 3 software 4 41 4.2 4.3 Apiil 1, 2015 OQ: Operational Qualification Scope The DataPro operational testing utilizes the user interface of DataPro in conjunction with a particle counter. The DataPro software uses Ethernet to communicate with a particle counter. The Revision History included at the end of the DataPro3 manual describes in detail the changes of each version. This is a supplemental validation of DataPro 3 using version 1.35 superseding any prior one regarding relevant tests, This version is a subsequent version to DataPro 3 version 1.34 and its validation documentation User Requirements U1.1.0. Change CLIMET DataPro 3 software package version number from V1.34 to V1.35 because of software change U1.2.0 Change CLIMET DataPro3 manual to indicate version change U1.3.0 Correct particle size and format on view alarms comments for Spanish versions of Windows. Functional Specifications The first functional requirement encompass’ both the client and the service projects. F1.1.0 Updated version number in DataPro software package. F14.2.0 Updated CLIMET DataPro3 Manual version numbers in title and filename. F1.3.0 Updated necessary code to correct particle size and formatting issues on view alarms comments for Spanish versions of Windows. DataPro 3 1.35, Validation Page 6of 9 P/N 03036901lation: DataPro 3 software 4.4 Traceability Matrix T ce ees a 7. Test or 1, URS Ee 4. GxP_ "4, | 6: Function Verification ‘CFRI1 Other 8 Reference 2. Description impact? Specification | Reference tr 2 Number impact? | vin) |'MPAt | Reference | (e.g. 10,00, | Comments wn) ers | Pq) | / t | i u110 | Software Package | oN N Nee aeons 4s | tet tHe Bee Ee | 1 | 120 Update Manual N N N F1.3.0 45 | | ui30 | Spanish oe sd N N N F1.3.0 46 DataPro 3 V1.35, Validation April, 2015 Page 7 of 9 P/N 03036901CME Validation: DataPro 3 software 45 Text Changes Purpose Observe that versions have been updated throughout product Setup Use the manual to determine the correct version numbering for the software package, the client and DAS. Procedure Check various places for correct version numbers. Manual of Client installation (About Pro Help Menu) Services menu and Task Manager. Success Low QNo Done by _ Date 4} - DataPro 3 V1.35, Validation April 1, 2015 Page 8 of 9 P/N 03036901CLiviie. 4.6 Purpose Setup Procedure Success Done by April 1, 2015 Validation: DataPro 3 software Spanish Windows 7 particle size formatting fix Test DataPro 3 V1.35 gives proper particle sizes and formats in the view alarm comments section while running on Spanish version of Window 7 DataPro 3 installation CD Virtual Machine/Machine running Spanish version of Windows operating system Launch setup for DataPro 3 of Install new DataPro V1.35 a, Set Alarms that will be met ad View Alarms and ensure particles in comments match sizes set des No DataPro 3 V1.35, Validation Page 9 of 9 P/N 03036901"ou epocara wrt g'9 2 uonmedo Uf ser a=uy UNe}—C aon0 oui wo) AreAoDoR ise} easy 1pe¥q