Deviations & CAPAs
Deviations and Corrective and Preventive Actions (CAPAs) are tracked in this module. All GxP-impacting deviations must be documented, risk-classified, and resolved within defined timelines. Critical deviations require immediate escalation and root cause analysis within 48 hours.
Deviations
53
CAPAs
27
Open / In-Progress
40
Critical
24
| ID | Type | Title | Severity | Owner | Due Date | Status | Created |
|---|---|---|---|---|---|---|---|
| DEV-001 | CAPA | Electronic signature not applied before document dispatch | Minor | Carlos Mendez | 2025-04-01 | In Progress | 2022-12-07 |
| DEV-002 | Deviation | Missed regulatory submission deadline for Type IB variation | Critical | Carlos Mendez | 2025-04-01 | In Progress | 2023-04-24 |
| DEV-003 | Deviation | Out-of-specification result for dissolution test batch 2024-087 | Minor | Carlos Mendez | 2025-03-25 | Completed | 2023-01-26 |
| DEV-004 | CAPA | Commitment due date missed: paediatric study report | Major | James O'Brien | 2024-12-24 | Open | 2023-07-02 |
| DEV-005 | Deviation | Incorrect version of SmPC dispatched to EU portal | Critical | Dmitri Volkov | 2024-12-13 | Completed | 2023-04-07 |
| DEV-006 | Deviation | Uncontrolled document used during regulatory review | Minor | James O'Brien | 2025-01-19 | In Progress | 2024-05-22 |
| DEV-007 | CAPA | Labeling text discrepancy between US and EU versions | Critical | Dmitri Volkov | 2025-01-15 | Closed | 2024-01-15 |
| DEV-008 | Deviation | Electronic signature not applied before document dispatch | Critical | Marcus Webb | 2025-04-04 | Completed | 2023-10-25 |
| DEV-009 | Deviation | Expired GMP certificate submitted in dossier package | Major | James O'Brien | 2024-12-27 | Completed | 2023-03-20 |
| DEV-010 | CAPA | Uncontrolled document used during regulatory review | Minor | James O'Brien | 2025-04-22 | Open | 2023-09-09 |
| DEV-011 | Deviation | Expired GMP certificate submitted in dossier package | Minor | Dmitri Volkov | 2025-03-11 | In Progress | 2023-11-05 |
| DEV-012 | Deviation | Expired GMP certificate submitted in dossier package | Major | Dmitri Volkov | 2025-03-07 | In Progress | 2023-02-25 |
| DEV-013 | CAPA | Labeling text discrepancy between US and EU versions | Major | Nadia Petrova | 2025-01-19 | Closed | 2024-06-01 |
| DEV-014 | Deviation | Incorrect version of SmPC dispatched to EU portal | Major | Marcus Webb | 2024-12-11 | Completed | 2023-12-03 |
| DEV-015 | Deviation | Expired GMP certificate submitted in dossier package | Major | Nadia Petrova | 2025-01-21 | Open | 2024-02-26 |
| DEV-016 | CAPA | Uncontrolled document used during regulatory review | Minor | Dmitri Volkov | 2025-04-30 | Open | 2023-10-04 |
| DEV-017 | Deviation | Missed regulatory submission deadline for Type IB variation | Critical | Dmitri Volkov | 2025-02-04 | Completed | 2022-11-13 |
| DEV-018 | Deviation | Labeling text discrepancy between US and EU versions | Major | Sarah Chen | 2025-01-18 | Completed | 2024-04-04 |
| DEV-019 | CAPA | Electronic signature not applied before document dispatch | Critical | Nadia Petrova | 2025-04-09 | Closed | 2023-05-01 |
| DEV-020 | Deviation | Uncontrolled document used during regulatory review | Critical | Nadia Petrova | 2024-12-10 | Completed | 2024-04-29 |
| DEV-021 | Deviation | Missed regulatory submission deadline for Type IB variation | Major | Carlos Mendez | 2025-01-13 | In Progress | 2023-02-25 |
| DEV-022 | CAPA | Publishing job failed due to invalid eCTD structure | Critical | Dmitri Volkov | 2024-12-15 | In Progress | 2024-01-19 |
| DEV-023 | Deviation | Labeling text discrepancy between US and EU versions | Minor | Lieselotte van der Berg | 2024-12-11 | In Progress | 2024-01-11 |
| DEV-024 | Deviation | Expired GMP certificate submitted in dossier package | Minor | James O'Brien | 2025-01-21 | In Progress | 2023-06-08 |
| DEV-025 | CAPA | Incorrect version of SmPC dispatched to EU portal | Critical | Priya Sharma | 2025-02-02 | Open | 2023-05-01 |
| DEV-026 | Deviation | Labeling text discrepancy between US and EU versions | Major | Lieselotte van der Berg | 2025-03-12 | In Progress | 2023-11-30 |
| DEV-027 | Deviation | Expired GMP certificate submitted in dossier package | Critical | Nadia Petrova | 2025-02-21 | Completed | 2023-09-18 |
| DEV-028 | CAPA | Commitment due date missed: paediatric study report | Major | James O'Brien | 2025-03-04 | Open | 2022-12-01 |
| DEV-029 | Deviation | Publishing job failed due to invalid eCTD structure | Minor | Carlos Mendez | 2025-01-17 | Completed | 2023-06-16 |
| DEV-030 | Deviation | Data integrity concern: audit trail gap in QC system | Major | Dmitri Volkov | 2025-02-12 | Completed | 2023-04-15 |
| DEV-031 | CAPA | Labeling text discrepancy between US and EU versions | Minor | Carlos Mendez | 2025-03-26 | In Progress | 2023-08-01 |
| DEV-032 | Deviation | Commitment due date missed: paediatric study report | Major | Sarah Chen | 2025-04-15 | In Progress | 2024-01-18 |
| DEV-033 | Deviation | Uncontrolled document used during regulatory review | Major | Sarah Chen | 2025-01-13 | Open | 2023-05-19 |
| DEV-034 | CAPA | Publishing job failed due to invalid eCTD structure | Critical | Carlos Mendez | 2025-01-31 | Completed | 2023-10-23 |
| DEV-035 | Deviation | Data integrity concern: audit trail gap in QC system | Major | Dmitri Volkov | 2025-03-02 | Completed | 2023-02-21 |
| DEV-036 | Deviation | Expired GMP certificate submitted in dossier package | Minor | Dmitri Volkov | 2025-03-28 | Open | 2024-05-15 |
| DEV-037 | CAPA | Electronic signature not applied before document dispatch | Critical | Priya Sharma | 2025-03-17 | Open | 2022-12-07 |
| DEV-038 | Deviation | Commitment due date missed: paediatric study report | Critical | Sarah Chen | 2025-02-04 | Completed | 2023-10-16 |
| DEV-039 | Deviation | Electronic signature not applied before document dispatch | Critical | Priya Sharma | 2025-02-20 | In Progress | 2023-04-06 |
| DEV-040 | CAPA | Commitment due date missed: paediatric study report | Major | Carlos Mendez | 2025-02-01 | Closed | 2024-06-05 |
| DEV-041 | Deviation | Expired GMP certificate submitted in dossier package | Minor | Tomoko Ikeda | 2025-01-02 | In Progress | 2023-01-07 |
| DEV-042 | Deviation | Publishing job failed due to invalid eCTD structure | Critical | Priya Sharma | 2025-01-29 | Open | 2023-05-03 |
| DEV-043 | CAPA | Commitment due date missed: paediatric study report | Minor | James O'Brien | 2025-02-22 | Completed | 2023-12-16 |
| DEV-044 | Deviation | Missed regulatory submission deadline for Type IB variation | Minor | Lieselotte van der Berg | 2025-01-08 | Completed | 2024-06-08 |
| DEV-045 | Deviation | Uncontrolled document used during regulatory review | Major | Tomoko Ikeda | 2025-02-28 | In Progress | 2024-01-15 |
| DEV-046 | CAPA | Missed regulatory submission deadline for Type IB variation | Minor | Nadia Petrova | 2025-02-07 | Closed | 2023-06-30 |
| DEV-047 | Deviation | Commitment due date missed: paediatric study report | Major | Carlos Mendez | 2025-02-13 | Closed | 2023-05-29 |
| DEV-048 | Deviation | Data integrity concern: audit trail gap in QC system | Critical | Nadia Petrova | 2025-03-11 | Closed | 2022-11-12 |
| DEV-049 | CAPA | Electronic signature not applied before document dispatch | Critical | Aisha Okonkwo | 2024-12-12 | Closed | 2024-06-01 |
| DEV-050 | Deviation | Expired GMP certificate submitted in dossier package | Critical | James O'Brien | 2024-12-16 | Completed | 2024-05-27 |
| DEV-051 | Deviation | Data integrity concern: audit trail gap in QC system | Major | Dmitri Volkov | 2025-04-08 | Completed | 2024-03-07 |
| DEV-052 | CAPA | Incorrect version of SmPC dispatched to EU portal | Critical | Marcus Webb | 2025-01-22 | In Progress | 2023-05-19 |
| DEV-053 | Deviation | Incorrect version of SmPC dispatched to EU portal | Critical | Dmitri Volkov | 2024-12-23 | In Progress | 2022-11-28 |
| DEV-054 | Deviation | Commitment due date missed: paediatric study report | Major | Dmitri Volkov | 2025-05-06 | Completed | 2023-02-17 |
| DEV-055 | CAPA | Missed regulatory submission deadline for Type IB variation | Minor | Aisha Okonkwo | 2025-02-18 | In Progress | 2023-03-30 |
| DEV-056 | Deviation | Data integrity concern: audit trail gap in QC system | Major | Marcus Webb | 2025-02-17 | Open | 2022-12-09 |
| DEV-057 | Deviation | Missed regulatory submission deadline for Type IB variation | Major | James O'Brien | 2025-03-29 | Completed | 2023-08-29 |
| DEV-058 | CAPA | Missed regulatory submission deadline for Type IB variation | Critical | Lieselotte van der Berg | 2024-12-17 | Closed | 2023-02-12 |
| DEV-059 | Deviation | Publishing job failed due to invalid eCTD structure | Major | Carlos Mendez | 2025-04-05 | Completed | 2023-11-01 |
| DEV-060 | Deviation | Expired GMP certificate submitted in dossier package | Major | Marcus Webb | 2025-03-07 | In Progress | 2023-02-06 |
| DEV-061 | CAPA | Missed regulatory submission deadline for Type IB variation | Critical | Lieselotte van der Berg | 2025-05-06 | Completed | 2023-02-02 |
| DEV-062 | Deviation | Data integrity concern: audit trail gap in QC system | Minor | James O'Brien | 2025-04-10 | Open | 2024-05-16 |
| DEV-063 | Deviation | Publishing job failed due to invalid eCTD structure | Major | Sarah Chen | 2024-12-24 | Closed | 2024-03-17 |
| DEV-064 | CAPA | Uncontrolled document used during regulatory review | Minor | James O'Brien | 2025-02-20 | Closed | 2022-11-02 |
| DEV-065 | Deviation | Publishing job failed due to invalid eCTD structure | Critical | Tomoko Ikeda | 2025-03-23 | Open | 2024-05-26 |
| DEV-066 | Deviation | Electronic signature not applied before document dispatch | Minor | Nadia Petrova | 2025-02-13 | Open | 2024-01-30 |
| DEV-067 | CAPA | Electronic signature not applied before document dispatch | Minor | Aisha Okonkwo | 2025-01-08 | Closed | 2023-05-22 |
| DEV-068 | Deviation | Data integrity concern: audit trail gap in QC system | Major | Carlos Mendez | 2024-12-20 | In Progress | 2024-05-19 |
| DEV-069 | Deviation | Data integrity concern: audit trail gap in QC system | Minor | Priya Sharma | 2025-02-03 | Completed | 2022-11-20 |
| DEV-070 | CAPA | Commitment due date missed: paediatric study report | Minor | Lieselotte van der Berg | 2025-03-25 | Completed | 2023-07-18 |
| DEV-071 | Deviation | Labeling text discrepancy between US and EU versions | Minor | Priya Sharma | 2025-02-17 | In Progress | 2023-04-09 |
| DEV-072 | Deviation | Electronic signature not applied before document dispatch | Minor | Marcus Webb | 2024-12-07 | Closed | 2023-08-04 |
| DEV-073 | CAPA | Publishing job failed due to invalid eCTD structure | Major | James O'Brien | 2024-12-19 | Completed | 2022-12-01 |
| DEV-074 | Deviation | Uncontrolled document used during regulatory review | Minor | Sarah Chen | 2025-04-19 | In Progress | 2023-03-24 |
| DEV-075 | Deviation | Expired GMP certificate submitted in dossier package | Minor | Priya Sharma | 2025-02-07 | In Progress | 2022-11-13 |
| DEV-076 | CAPA | Labeling text discrepancy between US and EU versions | Major | Tomoko Ikeda | 2025-04-04 | In Progress | 2024-02-04 |
| DEV-077 | Deviation | Incorrect version of SmPC dispatched to EU portal | Major | James O'Brien | 2025-04-19 | Open | 2024-01-27 |
| DEV-078 | Deviation | Uncontrolled document used during regulatory review | Major | Tomoko Ikeda | 2025-04-06 | Open | 2023-03-22 |
| DEV-079 | CAPA | Labeling text discrepancy between US and EU versions | Critical | James O'Brien | 2025-01-13 | Completed | 2024-03-11 |
| DEV-080 | Deviation | Missed regulatory submission deadline for Type IB variation | Minor | James O'Brien | 2025-01-15 | Closed | 2023-12-23 |