Organizations that are implementing manufacturing execution systems and GAMP 5 computerized systems need to ensure that computer systems are suitable for use and compliant with legislation.
Our services include:
- Designing a right sized process that includes assessing risk, and validation focused on patient safety, product quality and data integrity.
- Defining SOPs within the QMS to cover all activities from design to development to validation to operations to retirement.
- Assuring that the systems meet all defined performance and security requirements, and regulations like CFR, Eudralex and more.
- Ensuring that supplier quality conforms to manufacturer-supplier quality technical agreements.
With our life sciences validation and GxP experts, we can help you validate these systems by using a scientific risk-based approach that is repeatable and scalable.