Why Data Integrity Should be an Integral Part of the Pharma Biotech Industry Culture
Data integrity is the essence of GMP, the cornerstone of how the industry operates, and it is vital that all organizations embrace it to survive the rapidly changing life sciences landscape.
Data integrity is not just another hot topic in the Clinical Trial Supply Industry. It is not a new requirement, limited to computerized systems or just an issue observed in other geographical territories, plagued with poor Good Manufacturing Practice (GMP) issues in the past. It is the essence of GMP, the cornerstone of how the industry operates and it is vital that all organizations embrace it to survive the rapidly changing life sciences landscape. It affects companies across the globe, no one is exempt, with data integrity issues causing many problems throughout the clinical supply chain including: study delays, reworks, cost implications, or patient enrollmenT challenges. At the core of data integrity is patient-centric decisions, which ensure the quality, safety, and efficacy of Investigational Medicinal Product reaching the patient. Essentially, without integrity, your data is unreliable.
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