Short, useful articles for quality, validation, IT and compliance leaders in life sciences.
Sampling audit trails once a quarter was a reasonable compromise when systems were few. In a connected GxP landscape, the risk lives between systems — and between reviews.
Read articleA signed read-and-understood form proves someone opened a document. It does not prove they can follow it. Here is how to close the gap between training records and real competency.
Read articleCloud teams treat drift as a security issue. In a GxP environment, an undocumented change to a validated system is a compliance event — and it needs to be treated like one.
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