The International Society of Pharmaceutical Engineering publishes the Good Automated Practices Guides including GAMP from 2008 which coverscomputer system validation in general and a number of more recent guides on topics ranging from mobile apps to IT infrastructure control. The current list of available guides is: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized...
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The Good Automated Manufacturing Practice (GAMP) organization issued a final draft for review of a guidance for achieving Part 11 compliance for Electronic Records;Electronic Signatures. It is available at the link provided or go to www.gamp.org for more information.. GAMP Part11 draft Note: this is not an FDA Guidance. It was written by an industry...
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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
for more info!

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