Day

October 16, 2006
Recipient: Patterson Technology Center Inc. Product:EagleSoft software Date:10/24/06 Failure to maintain procedures for receiving and evaluating complaints by a fomally designated unit; failure to establish and maintain adequate procedures for implementing corrective and preventive action; failure to establish and maintain adequate design control procedures to ensure design procedures address the planning, inputs, outputs, review, verification,...
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SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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