LVS 95XX Series IQ/OQ Overview Iq Oq Brochure.en 20170525174523 0
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LVS® Barcode Verifiers LV S - 9 5 X X LVS-9510 Desktop Barcode Verifier LVS-95XX Series IQ/OQ Overview The “LVS-95XX Series Installation Qualification (IQ) and Operational Qualification (OQ) Guideline” assists in validating an LVS-95XX Series system. The document provides guidelines to determine if an LVS-95XX Series system meets IQ and OQ specifications and fulfills its intended purpose. The document can be modified to fit the specifications of the client’s validation protocol. LVS-9570 Desktop Barcode Verifier LVS - 95X X Se r ies : At a G l a n c e • Offline verification of barcodes to ISO/IEC standards. • Inspects all nine of the ISO (ANSI) parameters, plus added features of determining blemishes, opacity, and human readable validation. • Verifies 1D and 2D codes and reports all parameters as specified in the applicable symbology specification. For more information on this product, visit www.microscan.com. LVS - 95X X: Ava il a b le Sym b o l og ies Standard QR Code Micro PDF417 PDF417 Operational Qualification (OQ) Micro QR Code Aztec The purpose of OQ is to demonstrate that LVS-95XX system components operate correctly within established limits and tolerances. OQ sections include: 2D Stacked The purpose of IQ is to confirm that the LVS-95XX system was installed correctly. A series of questions are provided pertaining to the installation of the system. In addition, a Calibrated Conformance Standard Test Card for GS1 Symbols accompanies an LVS-95XX system purchase. The Test Card reports on several certified parameters. The LVS-95XX system must demonstrate its ability to stay within +/- 5 percentage points of the parameters listed on the Test Card. The IQ section provides a chart to document and verify each Test Card parameter. Postal Linear Data Matrix Installation Qualification (IQ) GS1 DataBar • Testing: This section is designed to certify that the system is working according to factory specifications and according to the following test methods: Linear codes (1D): ISO/IEC 15426-1:2000(E) Two-dimensional codes (2D): ISO/IEC 15426-2:2004(E) To pass the OQ test, each test label supplied with the package is graded twice. The First Test Overall Grade and Second Test Overall Grade must measure within +/- 0.3 of each other’s grade point average. The labels to be tested can be taken from the “LVS-95XX Series IQ and OQ Validation Guidelines,” supplied by the client, or a combination of both. The labels must have at least a 1.4 grade point average. • Operational Status: This section provides a series of questions about the operational status of the system. Continued on back LVS-95XX Specifications and Options • Support Documentation: This section verifies that supporting documentation is supplied with the system. Sample documents include the “LVS95XX Series Operations Manual,” Preventive Maintenance Schedule, and Certificate of Training Documentation. • Electronic Records and Signatures: This section provides a list of questions associated with the criteria of using Electronic Records and Electronic Signatures with the LVS-95XX system; this pertains to FDA regulations required under 21 CFR Part 11. • Training Documentation: This section provides a place for training instructors to document operational training session information pertaining to the calibration process; calibration test card replacement process; setup screen functions; system verification methods; printing and archiving reports; and software upgrades. 1 of 25 Items Included with Purchase 24 of 25 Code 39 Example 1D (Code 39) Barcode Data Matrix • Microsoft ® Word version of the “LVS-95XX Series IQ and OQ Guidelines” • Microsoft ® Word version of the “LVS-95XX Series Operations Manual” • One set of twenty five (25) challenge barcode labels (1D and 2D barcodes) for testing (see example images) Example 2D (Data Matrix) Barcode 22 of 25 GS1-128x/CC-C Example 2D (Data Matrix) Barcode SAFETY CERTIFICATIONS DESIGNED FOR FCC, CE, UL (Pending) ROHS COMPLIANT QMS CERTIFICATION www.microscan.com/quality ©2017 Microscan Systems, Inc. ML052B-EN-0217 Warranty – For current warranty information about this product, please visit www.microscan.com/warranty. ISO 9001 Registered www.microscan.com
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