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Data Integrity Regulations for Pharma: Recent Trends and Future Direction

Driven by globalization and cost-saving demands, the drug-making process has increased in complexity over the last two decades. The separation of key drug development steps such as active pharmaceutical ingredient (API) creation, clinical trials and product manufacturing, often span different locations and can be carried out by various companies across the globe. Therefore, in order to improve traceability of data and improve drug quality, data integrity guidelines are necessary.

Download this whitepaper to learn more about how these regulations are assisting with:

  • Addressing quality challenges in drug manufacturing
  • Efforts to cope with increasing quality issues
  • Supplier strategic efforts to assist in quality improvements