A thorough GMP risk assessment forms the basis for successful validation and compliance with regulatory requirements. In our workshop, we identify potential risks across the different process phases and develop tailored solutions for risk mitigation. In doing so, we take both technical and operational aspects into account to ensure an efficient and safe production environment.

A precise specification is the key to smooth project execution. We prepare detailed requirement profiles for the functionality of your packaging machine, including the necessary hardware and software. This ensures that the entire system architecture is optimally tailored to your needs while meeting all regulatory requirements.

The Factory Acceptance Test (FAT) is an essential part of the qualification process. During the FAT, we verify that the machine operates according to the defined specifications and meets the required performance parameters. In close collaboration with you, we test the machine functions and ensure that all required documentation is complete – ready for the next commissioning phase.

The Site Acceptance Test (SAT) takes place after the installation of the machine at your site. Together with you, we verify the functionality of the system under real operating conditions. In doing so, we ensure that the machine delivers the desired results and that all processes are carried out as planned. The SAT is a crucial step for successful handover and start of production.

According to EU GMP guidelines, manufacturers of pharmaceuticals and medicinal products must qualify their systems to demonstrate suitability for the intended purpose. We support you with both Installation Qualification (IQ), to ensure that the machine has been installed correctly, and Operational Qualification (OQ), where we verify its functionality in accordance with the specifications. Both qualifications are essential to guarantee the compliance and efficiency of your packaging solutions.

The traceability matrix is an important tool for documenting the traceability of all relevant requirements and tests. It provides a systematic link between specifications, tests and results, ensuring that every requirement is fulfilled throughout the entire validation process. This matrix is essential for transparency and for audits to demonstrate regulatory compliance.