Our client is a subcontractor for hormonal gels and solutions. Following the Authorities’ visit, a Remediation Plan was built in order to improve the quality system in general and more specifically:
- Deviations management (efficiency, robustness, and backlog resolution)
- Q&V system
ALTEN was chosen to do the Remediation Plan Execution.
ALTEN ACTIVITIES
A dedicated team on the client site took the lead on:
- QA System
- Documentation Management System redefined
- Write the missing or obsolete SOP
- Reduce backlog on deviations
- Coaching of QA Operational team
- Resolution of CAPA linked to Validation
- TIER Management to secure the start-up of serialization
STANDARDS AND TOOLS
- Good Manufacturing Practices ( Annex 15-Validation)
- TIER Management
- Equipment knowledge with a focus on Serialization
- Local procedures
- Microsoft Office (Word Excel, PowerPoint, Outlook)
- Relationship skills
ALTEN ADDED VALUE ▸ Setting up one single team that manages the approach and deployment of actions necessary to fit with Authorities’ requirements
▸ Challenge and improve Customer Internal Processes
▸ Train and develop internal employees
▸ Reconnect the different Departments
