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Considerations for safety data migration methods

European Pharmaceutical Review

Pharmaceutical companies regularly transfer databases as they shift to new systems or change service providers in pursuit of higher quality and increased efficiency. However, due to configuration differences between databases (such as code list definitions), cases may not always be an exact replica of the original case.

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Deviation investigation guidelines in the pharmaceutical industry

GMPSOP

incorrect data entry). 1 – No chance of occurrence 2 – Chance of occurrence is remote 3 – Occurrence is unlikely 4 – Occurrence is probable 5 – Occurrence is definite Overall risk score: Severity X Probability The tool can also be used for analysing a manufacturing process to identify high risk steps / critical parameters.