An effective CAPA systems requires precise deviation reporting, thorough investigations, a CAPA system and Change Control.
We offer you our CAPA Quartet package at a reduced rate to the individual SOPs.
Our Change Control SOP meets the requirements of the 2019 PIC/s draft Guidance for inspectors on Change Management.
These four SOPs represent the core of CAPA management and together with a robust batch record review procedure (watch this space) allow a company to set up, maintain and continually improve the Quality System.  
(1) CAPA is the envelope – you may have an electronic / hybrid or paper-based system.  
(2) Changes are the outcome of risk assessments, audits, complaints, deviations and other quality related events whether proactive or reactive.  
(3) Deviations are reactive and need clear documentation to allow a thorough. 
(4) Investigation which allows determination of product impact assessment and appropriate and effective corrective action.
 
Contains:
- CAPA SOP (PDF & .docx)
- CAPA Tracking Sheet (PDF & .docx)
 
- Change Control Policy (PDF & .docx)
- Change Control Process Flow (PDF & .docx)
- Change Control Proposal Form (PDF & .docx)
- Change Control Form (PDF & .docx)
- Change Control Plan (PDF & .docx)
- Change Control Logbook (PDF & .docx)
 
- Deviations SOP (PDF & .docx)
- Deviations Report Form (PDF & .docx)
- Deviations logbook (PDF & .docx)
 
- Investigations SOP (PDF & .docx)
- Investigations Checklist (PDF & .docx)
- Investigation Plan (PDF & .docx)
- Examples for Root Cause Analysis Brainstorming Hypotheses (PDF & .docx)
- Process Flow for Conducting an Investigation (PDF & .docx)
- Guide for Investigation Team (PDF & .docx)