Fields
| Section Name | Field Name | Description |
|---|---|---|
| Investigation Required | Yes: investigation is required No: investigation is not required |
|
| Severity | Severity of the investigation. Possible values are High, Low, Medium, and Urgent. | |
| Location or Site | Name of the location where the investigation was performed | |
| Reference Type This field is applicable only for NCs. | Reference type for the investigation process. Possible values are CAPA, External CAPA, NC, and External NC. | |
| Method | Investigation method code | |
| Results | Investigation result code | |
| Conclusion Code | Investigation conclusion code | |
| Rationale | Reason provided by the investigator to select the conclusion code | |
| Approval Sign-off | Responsible Investigator | Name of the investigator |
| Completion Date | Date when the investigation was completed | |
| Risk Analysis This section is applicable only for Complaints, ESRs, and Inquiries. | Risk Analysis Required | Yes: risk analysis is required No: risk analysis is not required |
| Comments | Reason provided by the investigator about the risk analysis requirement | |
| Conclusion | Malfunction | Yes: problem occurred due to malfunction No: problem did not occur due to malfunction |
| Packaging/Labeling Problem | Yes: problem occurred due to packaging or labeling issue No: problem did not occur due to packaging or labeling issue | |
| Use Error | Yes: problem occurred due to wrong usage No: problem did not occur due to wrong usage | |
| Recommended Actions | Recommendations provided by the investigator | |
| Summary Details | Summary of the investigation | |
| Additional Information | Additional information about the investigation and conclusion |