Deviation Management
Fictional document for the demonstration.
Version history
- Version 6.0Effectivesince 2026-03-02
- Version 5.0Superseded2024-09-02 to 2026-03-02
§4.1 Classification
Every deviation is classified as minor, major or critical according to its potential impact on product quality, patient safety and data integrity. Classification is confirmed by Quality Assurance within one working day.
§4.2 Storage and temperature excursions
Any storage or temperature excursion outside validated limits requires the affected stock to be quarantined immediately. An impact assessment, using stability data, must be completed within five working days before any stock is released.
§4.3 Documentation corrections
A documentation error is corrected with a single line-through, the initials of the person correcting it and the date, so the original entry stays legible. A correction made under good documentation practice does not need a deviation unless data was lost.
§5.1 Closure
A deviation is closed only when the root cause is documented, the impact on released product is assessed and any corrective action is linked to a CAPA.