Incident Management & CAPA
A complete incident handling, deviation management, and CAPA system tailored for pharmaceutical operations in Kenya.
What's Included
A comprehensive incident management system covering every aspect of deviation handling, investigation, and corrective action.
Project Timeline
A structured 3-phase approach over 3-6 weeks to build and launch your incident management system.
Assessment
Week 1-2
- Current incident handling review
- Gap analysis
- Risk assessment
System Design
Week 3-4
- Procedures
- Forms & classification matrices
- Investigation templates
Implementation
Week 5-6
- Staff training
- Pilot investigations
- System go-live & monitoring
Who Is This For?
This service is designed for pharmaceutical companies that need a structured approach to handling quality incidents.
Companies with no formal incident reporting or CAPA system in place
Organizations that have experienced product quality issues or recalls
Businesses needing to strengthen deviation management for PPB compliance
Frequently Asked Questions
What types of incidents does this cover?
All pharmaceutical quality incidents: product deviations, temperature excursions, contamination events, customer complaints, storage failures, transportation incidents, and product recalls.
Can this integrate with our existing quality system?
Yes, we design the incident management system to integrate seamlessly with your existing quality framework, document control, and reporting structures.
Do you help with active incident investigations?
Yes, we can assist with ongoing investigations as an add-on service. Hourly consulting rates apply for live incident support.
Strengthen Your Incident Response
Build a robust incident management and CAPA system that protects your products, patients, and business.
Get Started TodayFree consultation included -- no obligation