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