deviation description
IRI: https://spec.industrialontologies.org/ontology/construct/DeviationDescription
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaDeviationManagement/
SubClass Of: information content entity
Class Hierarchy
owl:Thing › bfo:entity › bfo:continuant › bfo:generically dependent continuant › information content entity › deviation description
Definition
information content entity generated as part of deviation management to describe the occurrence and relevant circumstances of a deviation event
Examples
- Description of an occurrence during buffer preparation in which the measured pH was beyond the applicable limit
Adapted From
- https://www.bioprocessintl.com/qa-qc/biopharmaceutical-quality-managing-good-manufacturing-practice-deviations and https://www.biopharminternational.com/view/risk-based-approach-deviation-management
Primitive Class
This class is declared primitive and it does not have necessary and sufficient condiftions defined.
Primitive Rationale
There are insufficient constructs to create a set of necessary and sufficient conditions.
Formal Axioms
First-Order Logic Axioms
DeviationDescription(x) → InformationContentEntity(x) ∧ ∃y (describes(x, y) ∧ DeviationEvent(y))
Semi-Formal Natural Language Axioms
if x is a ‘deviation description’ then x is an ‘information content entity’ that ‘describes’ some ‘deviation event’