Day

December 19, 2014
Novacyl Wuxi Pharmaceutical Co., Ltd. .Product: pharmaceutical manufacturing facility Date: 12/19/2014 1. Failure to manage laboratory systems with sufficient controls to ensure conformance to established specifications and prevent omission of data. Our inspection revealed serious deficiencies related to your documentation practices, including missing raw data. It is a basic responsibility of your quality unit to...
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Remote Webmeeting Assessments

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

Email office@softwarecpr.com
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