Day

May 7, 2014
Sun Pharmaceutical Industries Limited Product: pharmaceutical manufacturing facility Date:5/7/2014 1. Failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards. our firm frequently performs ?unofficial testing? of samples, disregards the results, and reports results from additional tests. For example, during stability testing, your...
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Company: Hospira Inc..Date of Enforcement Report:5/7/2014 Class I: PRODUCT GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX Recall Number Z-1512-2014 REASON There...
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Company: GE Healthcare LLC Date of Enforcement Report:5/7/2014 Class lI: PRODUCT GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #’s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI is an analytical software tool, which provides reproducible tools for the review and reporting...
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Company: Brainlab AG Date of Enforcement Report 5/7/2014 Class lI: PRODUCT ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X...
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Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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