Skip to content
Synapse Soft

From deviation to root cause, close recurring errors for good

Collect production deviations, OOS/OOT lab results and internal audit findings in one place; dig to the root cause with 5-Whys and Ishikawa and tie it to a corrective and preventive action.

Quality events and root-cause analysis
21 CFR 211.192EU GMP Chapter 1ICH Q9(R1)

Deviation, OOS and CAPA Management

Axon · CAPA

Illustrative interface rendering. Real screens and recordings live on the module pages.

Deviation, OOS and CAPA Management

Who it is for: QA event managers, production supervisors, QC lab leads

  1. Immediate containment

    When a deviation is detected, the affected batch, raw material or equipment is blocked in the system; nothing moves on until risk is contained.

  2. Root-cause logic that challenges "operator error"

    A record cannot be easily closed as "user error" before process and equipment weaknesses are examined.

  3. Visual 5-Whys and Ishikawa

    Maps cause and effect step by step and ties the root cause directly to a CAPA action.

  4. Verification of effectiveness (VOE)

    Automatic follow-up that tests whether the measure worked after a set period or number of batches.

Make audit day an ordinary day.

In a short demo we look at your own use case together.