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Watch Roche’s Case Study on Data Integrity and Audit Trail Review in MES

Fill in the form below to view the case study from Peter Bosshard, Quality Manager at F. Hoffmann-La Roche AG as he shares his expertise on Data Integrity and Audit Trail Review in Manufacturing Execution Systems.

In his exclusive case study, Peter Bosshard, focused on the following topics:

  • What is the meaning of Data Integrity and Audit Trail and how should it be reviewed?
  • Audit Trail vs. Log vs. Version Control vs. Revision Control
  • Current and changing regulatory requirements on Data Integrity and Audit Trail Review?
  • Observations and warning letters from the Regulators (US-FDA)?
  • Best practice on implementation in MES
  • System audit trail settings
    • Operations audit trail
    • Audit trail review reporting
    • Business value beyond compliance

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