VIV Podcast

Audit Trails and Data Integrity in Pharmaceutical and Life Sciences

On today's episode we invited Ivan Soto, Director Manufacturing Validation for Emergent BioSolutions, to help us cover a variety of aspects around the topic of data integrity.

Highlights from this episode include:

  • Why are we hearing more about audits and audit reviews lately?
  • Ivan talks about the history of audit trail reviews and the current challenges
  • Why are audit trails important to safety, efficacy and reliability or pharmaceuticals and how does that impact data integrity efforts?
  • Why is it important to assess the products’ entire legacy or history?
  • Ivan shares advice on the frequency of periodic reviews and what should be included in those reviews
  • He shares some tips for simplifying the review process
  • Where does Ivan see the industry moving regarding audit trails?




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