March 6, 2014
USV Limited Product: pharmaceutical manufacturing facility Date:3/6/2014 1. Failure to maintain complete and accurate laboratory test data generated in the course of establishing compliance of your APIs to established specifications and standards. a. There was no written explanation for deletion events observed on audit trails for your standalone HPLC units. Your standard operating procedures (SOPs)...
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The Office of National Coordinator for Health Information Technology published a proposed rule for Voluntary 2015 Edition Electronic Health Record Certification Criteria; Interoperability Updates and Regulatory Improvements. The proposed rule eliminates the “complete EHR” designation, separates the content and transport certification criteria and announces a more frequent certification rule making process. The proposed rule also...
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There is a new draft for vote of ISO 13485 Medical Devices – Quality Management systems – requirements for regulatory purposes. This version updates the references to ISO 9001 to the 2008 version. Some new requirements include: A requirement for a risk management process has been added in the product realization phase and ISO 14971...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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