Glossary
Hybrid System
A system in which paper and electronic records together make up the complete record of one GxP activity.
Source · MHRA GxP Data Integrity Guidance (2018), §4.3 Hybrid
Details
In a hybrid system neither the paper nor the electronic component alone completes the activity, so the two must be cross-referenced and reviewed together. Inspections cite review of the paper printout alone with the electronic raw data and audit trail omitted, and discrepancies between the two records that were never noticed. Check the data flow diagram, the identifiers linking the records, the review SOP, the electronic raw data and paper records, and retention and retrieval testing.
Related sections
Related terms
Source
MHRA GxP Data Integrity Guidance (2018), §4.3 HybridGRM Regulatory Glossary
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