Partnership for Your Success
Cape7 has extensive experience in all phases of production equipment design, planning, procurement, realization, and installation in regulated environments. Over the years, Cape7 has also supported various infrastructure projects. To achieve GxP compliance, the V-model project management approach is typically used. This systematic approach facilitates compliance with GMP regulations. In addition to traceability, it ensures that the requirements for hygiene, facilities, equipment, documentation, and controls are met. Qualification documents are created and archived according to the EU-GMP guidelines. Internal standards are generally used for qualification and validation.
Our industry-specific competencies and expertise include:
- Deep Understanding of the Pharmaceutical Industry: Our experts possess profound knowledge of the specific requirements and regulations of the pharmaceutical sector. We are aware of the current trends and developments and can develop tailored solutions for your company.
- Extensive Experience in GxP Compliance: With our expertise, we help you adhere to the stringent guidelines of GxP compliance. We ensure that your production facilities and processes meet regulatory requirements and that all necessary qualification and validation documents are correctly created and archived.
- Efficient Project Management: By using the V-model in project management, we ensure a structured and effective implementation of your projects. We adhere to schedules, control costs, and ensure transparent communication throughout the entire project.
- Customized Solutions for Your Needs: Every company is unique, which is why we develop individual solutions tailored precisely to your needs. With our industry-specific know-how and experience, we can successfully tackle even complex challenges.
