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Covid-19 also poses challenges to Life Science, especially within GMP-regulated environments

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E.g., how do you comply with the regulatory requirements within Data Integrity in your company in connection with homework? Are you aware of the potential deficiencies?

Especially, be aware of that the FDA has expanded the scope on Data Integrity to also now include IT security.

Therefore, as a GMP manufacturer, you must pay careful attention to potential breaches of regulatory requirements on Data Integrity in connection with employees working from home connected to your GMP environment from their private network.

We have put together a portfolio of different input on Data Integrity in general. Please find below 2 video interviews with experts with Data Integrity, incl. a pod cast.

 

 

 

 

#2 The authorities have gained an increased focus on data integrity

This episode is the second of a series of Podcasts where our CEO Henrik Johanning discusses topics with different Life Science specialists.
In this episode, Henrik Johanning has invited counselor Michael Weng, who is a specialist within Computer System Validation (CSV) and Data Integrity, to a talk where they include:

  • Data
  • Inspection Readiness
  • IT-systems

And why it is so important to map the data flow to be able to make the necessary risk assessment.
The whole talk is in Danish.

 

 

Finally, we have published an E-book, which contains among other things 5 basic principles for good GMP Data Control & Data Integrity

 

Free E-book about Data Integrity

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ISO 27001 Information security

Genau & More has been to be certified in relation to ISO 27001: 2017 (Information security) as one of the few consulting engineers and consulting houses. We have been doing this since 2014.

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If you want to hear more about how Genau & More can help your company, please contact

Simon Bagger

COO, Partner & Senior Consultant
IT & Automation / GAMP, Project Management, GMP, Computer System Validation, SAFe

Henrik Johanning

CEO & Senior Consultant
IT & Automation / GAMP, Project Management, Management Consulting, GMP, Regulatory Affairs, Training

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FDA Inspections during COVID-19 pandemic

John Lee, Video 1 of 9

Novel / Recurring deficiencies causing a FDA Warning Letter.

John Lee, Video 4 of 9