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Pharmaceutical & Medical Packaging News, September/October 2015

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pmpnews.com • Pharmaceutical & Medical Packaging News September/October 2015 30 Vision Inspection automatically validate bar code infor- mation against standard GS1 Applica- tion Identifiers. No programming is required. The application is configured by following step-by-step menus to set up the job parameters. On-line grad- ing is used as a feedback tool to tell you whether print quality has changed, which could mean it's time for preven- tative maintenance such as cleaning the print heads on a printer. An audit server can also be used t o t r a c k s i g n i f i c a n t e v e n t s . T h e application includes a password- protected user account control, with parameter access control for diferent user groups. An audit server runs on a PC and tracks significant events on the camera. When the audit server is enabled, cameras send XML for- matted messages to the audit server application whenever a user logs in, changes a job, puts the camera on- line or of-line, and changes a param- eter. If the audit server is down, the camera will bufer up to 1000 events and then transmit them after the con- nection to the server is restored. This approach meets the requirements established by the FDA's 21 CFR Part 11 regulations for electronic sig- natures and records. IQ/OQ VAlIDAtION DOCUMeNtAtION The use of a pre-written job tem- plate minimizes the amount of work required to validate the line. Tem- plates are provided for the Functional Specification (FS), Design Specification (DS), Installation Qualification (IQ), Operational Qualification (OQ), and a corresponding Trace Matrix docu- ment that ties these documents togeth- er as required by GAMP V validation procedures by correlating the FS and DS to the IQ/OQ documents. CONClUsION Recent technology advancements are benefitting medical device manufactur- ers and other supply chain contributors rushing to comply with UDI regulations. For example, in the vision-based ID reader space, software algorithms have been developed that are able to find and decode even damaged and poorly marked 1-D or 2-D codes through a wide range of illumination, marking, and material variations. OCR software has been developed that can read text even when there is little contrast between type and background and when letters are touching, skewed, and distorted. These advancements will help position the medical device supply chain to achieve compliance with current and future reg- ulations, reduce costs, and improve the security of their supply chain. For more information, contact Cognex, One Vision Drive, Natick, MA 01760-2059 USA. Tel (Toll Free): 877/COGNEX1 (877/264- 6391), Fax: 508/650-3344, Email: pr@cognex.com, Web: www.cognex. com. For additional information about marking requirements for the UDI ini- tiative, visit the GS1 Web site at www. gs1.org/healthcare/udi or www.gs1. org/docs/healthcare/UDI_Leaflet_ Final.pdf. 0 COGNEX 6.1.1 VERIFICATION OF COGNEX IN-SIGHT TRACK & TRACE V2.0 HMI MAIN SCREEN Train. No Procedure Details Expected Result As Expected, YES/ NO? If No, Explain Initials / Date Incident Number Confidential TITLE: Installation and Operational Qualification Protocol for In-Sight Track & Trace v2.0 6.1.1.1 6.1.1.2 6.1.1.3 6.1.1.4 6.1.1.5 Navigate to Windows Start Menu>all program>Cognex>Insight >In-Sight Track & Trace 2.0.0 and launch Cognex HMI Control Display Sample Components. Enter the IP address of the camera in the connection IP Address field and enter user name and password in the connection user name and password field of the vision system and click Connect. Connected to In-Sight vision system and the Main Screen of the Track & Trace v2.0.0. Verify Sample Control Window allows the user to select Particular Symbolic Tag and perform the Set Value function. Verify that the Sample Control window allows the user to save jobs to In-Sight. Sample Control window allows user to save jobs to In-Sight. From the Main Screen Verify that the HMI Screen displays the following: Performed By: __________________________________ Reviewed By: __________________________________ Date: ________________________ Date: ________________________ The following options are displayed: • Setu p • Change Batch • Statistics • Setup • Change Batch • Statistics Sample Control Window allows the user to select Particular Symbolic Tag and perform Set Value function. IP Address: The Sample Controls dialog window opens. Note: This section of the test script is for the testing of the included HMI Control Display included in the Cognex Track and Trace v2.0 Software. The HMI Control Display is an optional piece of software and can be replaced by 3rd party programs. If 3rd party software is used, this section may be skipped and marked Not Applicable (N/A), and an additional test script should be used to confirm the buttons tested in section 6.1.1.5 DOCUMENT NUMBER: Page 20 of 108 Category: Effective Date: To help customers minimize deployment costs, Cognex can provide IQ/OQ documentation.

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