Processes: Deviation & CAPA
No processes match the current filters.
Deviation Management
Deviation & CAPA
ID: P036
A systematic GxP deviation management process defined in POL-0300118 for identifying, reporting, investigating, documenting, correcting, and preventing deviations from approved GxP standards. Based on criticality, a formal root cause analysis is performed, scope defined, and mitigation actions imple
Source Documents (1)
Mapped Citations (14)
- 16.2 Establish and Maintain a Process to Accept and Address ...
- 16.3 Perform Root Cause Analysis on Security Vulnerabilities
- 18.3 Remediate Penetration Test Findings
- 7.2 Establish and Maintain a Remediation Process
- 7.7 Remediate Detected Vulnerabilities
- AIS-07 Application Vulnerability Remediation
- CM.AW-P8
- GRC-04 Policy Exception Process
- GV.MT-P5
- ID.RA-P5
- Incident Management
- Infrastructure Exceptions
- Security Exceptions
- Validation Documentation (Change control and Deviations)
Artifacts (1)
GxP Issue Escalation and Deviation Management
Deviation & CAPA
ID: P044
Workflow for managing unplanned occurrences affecting GxP computerised systems, from initial incident detection through classification, notification, root cause investigation, and corrective action linkage. Defined in AGR-0304935 as a coordinated process between Contract Giver (PT) and Contract Acce
Source Documents (2)
Mapped Citations (34)
- 17.2 Establish and Maintain Contact Information for Reportin...
- 7.2 Establish and Maintain a Remediation Process
- AS.164.308.a1-ii-d
- AS.164.308.a6-i
- AS.164.308.a6-ii
- Assessment and decision on information security events
- Audit Log Event Review
- CM.AW-P7
- Collection Of evidence
- DE.AE-02
- DE.AE-04
- DE.AE-06
- DE.AE-08
- Devise Organization-wide Standards for Reporting Incidents
- Document Incident Response Procedures
- Establish a Process to Accept and Address Reports of Softwar...
- GV.RM-05
- ID.RA-08
- Incident Management
- Information security event reporting
- Information security incident management planning and prepar...
- Learning from information security incidents
- Maintain Contact Information For Reporting Security Incident...
- Maintenance, Monitoring and Analysis of Audit Logs
- RS.AN-03
- RS.AN-06
- RS.AN-07
- RS.CO-02
- RS.CO-03
- RS.MA-02
- RS.MA-04
- Response to information security incidents
- SEF-06 Event Triage Processes
- SEF-07 Security Breach Notification
Roles (6)
Artifacts (2)
RDT Deviation and CAPA Management
Deviation & CAPA
ID: P066
SOP-0303148 defines a systematic 6-phase workflow for managing GxP deviations within RDT, covering identification and creation, impact assessment and risk classification, root cause analysis, CAPA planning, implementation, and effectiveness monitoring. The process applies risk-based controls (Low/Me
Source Documents (1)
Mapped Citations (8)
Roles (5)