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2022 ISPE Annual Meeting & Expo

SES205c - Data Integrity Surveillance Program for GxP Suppliers

Nov 1, 2022 10:45am ‐ Nov 1, 2022 12:15pm


Worldwide Regulatory Authorities have become more and more focused on Data Integrity as the Regulated Companies are required to strictly ensure the reliability of records, which are ultimately determined by the Computerized Systems managing these records and determined to have a potential impact on Patient Safety and Product Quality. This regulatory expectation is required to be met in the globalized industry, which has increased the complexity of the supply chain network for all the business spaces, including the pharmaceutical products which result in higher efforts and costs from regulated companies are required to ensure integrity of data (and ultimately the quality of products and safety of patients), provided or enabled by the different GxP supplier across the whole supply chain.

The presentation will show a business case with a practical model that allows establishing a cost-effective Data Integrity Surveillance process, keeping in mind the reshoring effect cause by the pandemic phenomena since 2020.


  • Danilo Neri, Vice President Operations - Partner, PQE Group

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