Ensuring Compliance with Regulatory Standards
At confinis, we specialize in the validation and qualification of manufacturing processes and equipment for industries that produce food, medicines, and medical devices. It is crucial that these processes are validated to comply with stringent regulatory standards, ensuring that products are consistently produced and controlled according to quality standards.
GMP Validation
Our validation services adhere to Good Manufacturing Practices (GMP), which are recognized internationally by the industry as well as by auditors and inspectors. GMP validation is essential for demonstrating that manufacturing processes are capable of producing outputs that meet quality specifications consistently.
Equipment Qualification
We ensure that manufacturing equipment is properly qualified, which includes Design Qualification (DQ), Installation Qualification (IQ), and Operational Qualification (OQ). This is a prerequisite for the successful Process Qualification (PQ) of manufacturing processes.
Specialized Computer System Validation (CSV)
Comprehensive Validation Support
For automated systems driven by computer processes, confinis provides Computer System Validation (CSV) according to GAMP5 guidelines. This specialized validation is critical for ensuring that computerized systems will perform accurately and consistently as intended, underpinned by detailed documentation.
confinis offers extensive experience in risk-based and efficient validation of manufacturing processes in regulated environments. We assist clients from the creation of validation plans to the execution of the validation activities themselves, ensuring compliance and operational excellence.
Why is it important?
Proper validation and qualification demonstrate the quality and efficiency of manufacturing processes and computer systems, helping to maintain regulatory compliance and product quality.
