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Anna Lundén talks about tendencies and developments to be found in observations and warning letters

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Tendencies and developments to be found in observations and warning letters.
Non-compliance issues tend to be on computerised systems and especially within issues on data integrity. This eventually documents, that regulatory authorities now are looking for e.g. data integrity non-compliance issues.
Medicines and Healthcare Products Regulatory Agency in the UK (MHRA) has published a GMP Data Integrity guideline (March 2015)

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