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2020 ISPE Annual Meeting & Expo


NA20CENOV1/SES214 - GAMP® Data Integrity by Design (Part 2)


Nov 5, 2020 9:30am ‐ Nov 5, 2020 11:00am

Description

GAMP® Data Integrity by Design (Part 2) | With the large volume of data being generated there need to be metrics and business rules to detect potential issues to control the integrity of the data. With continued outsourcing there is also a significant need to manage the integrity of the vendor’s data that could affect the parent company’s products. Regulatory agencies are now starting to indicate the need to manage all electronic records over the entire retention period to assure that integrity was maintained back to the original raw data records. (Presentation 1) Clearly defined business rules and metrics derived from these rules will form an important foundation to efficiently detect potential data integrity problems during review for early intervention before they impact quality and safety. (Presentation 2) Without “Vendor 2.0” there cannot be Pharma 4.0: Applications in managing the integrity of the data generated at contract vendors poses a significant challenge that must be addressed if the industry wants to make Pharma 4.0 a reality. (Presentation 3) Practical approaches and strategies will be given for maintaining access, readability, and the Data Integrity principles in records created with legacy software packages that are no longer in production use including case studies.

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