Project action log, deviations and CAPA support
Quality support
Connects action history, deviation control, corrective measures and supporting evidence in the working flow.
Module purpose
Make quality part of daily execution rather than a retrospective collection of disconnected traces before an audit.
Status
Public clinical and operational validation results and medical-device registration details have not been published. This module must not be treated as an approved medical device. Human approval remains mandatory for clinical, ethical and regulatory decisions.Public clinical and operational validation results and medical-device registration details have not been published. This module must not be treated as an approved medical device. Human approval remains mandatory for clinical, ethical and regulatory decisions.
Inputs
- Event and version log
- Deviations and possible non-conformities
- Ethics decisions and approved documents
- CAPA, deadlines and evidence
How it works
- Links a signal to source and rule
- Assigns a working status for expert review
- Creates review and control checkpoints
- Checks the completeness of closure evidence
Outputs
- Project action log
- Draft deviation record
- Draft CAPA record and monitoring
- Materials for expert review
Human checkpoints
- Deviation classification
- CAPA approval
- Human closure and effectiveness review
Automation boundaries
- Does not certify compliance
- Does not replace auditors or ethics committees
- Does not rewrite primary evidence
Module video
Quality-process and documentation support
The film explains the module with a synthetic example. It is not evidence of clinical effectiveness, validation, compliance or regulatory approval.
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