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?