Deviation and CAPA Investigators
Writing a deviation or CAPA records demands excellent writing skills. It requires a good understanding of the defect, which affect it has on your process and which actions should be in place to control the risks and create actions to prevent future issues.
Speaking from experience, we know that almost every organization is struggling to stay in compliance when it comes to deviations and CAPA activities. During inspections deviations and CAPA topics are always included in the scope, and mostly observations are found and raised.
The most common issues are:
- Incorrect wording
- Defect record missing clear root-cause analyses
- Overdue: agreed internal dates are not meet (backlog)
- No effectiveness checks in place
- No overview of outstanding defects and CAPA records
- Tool or system for deviations/CAPA missing compliance aspects
- Missing QA sign offs
- No training actions after deviation and part of CAPA
Rescop has dedicated deviation and CAPA investigators, who are able to assist your department/organization. For some clients we have a remote team (working from our HQ office) working and accessing client IT systems to write deviation and CAPA records.
Next to ongoing deviation and CAPA records, Backlog remediation activities, Rescop can also train your department/organization.
- How to write effective deviations and/or CAPAs
- How to write and execute effectiveness checks (including effective monitoring activities)
- How to prepare and build-in permanent inspection readiness (PIR) aspects in relation to deviations and your CAPA process
- Creating or revising your internal procedures
- Setup management reports and KPI’s
Rescop is active in the following industries