Med'In QARA - Environment, manufacturing process and software validation
Validation of manufacturing processes and software
With Med'In QARA, we help you validate your manufacturing processes and software to ensure compliance with standards and best practice guidelines (GHTF/SG3:2004, FDA Guides or Eu-GMP Annex 15).
This starts with the implementation of quality documentation (procedures, forms, etc.) needed to structure each stage of the validation process.
The creation of qualification and validation files follows a methodical approach, involving the establishment of a Validation Master Plan, Design Qualification (DQ), Installation and Equipment Operational Qualification (IQ/OQ), Process Operational Qualification (PQ), and Process Performance Qualification (PQ). Protocols and reports document each phase and demonstrate process compliance, reproducibility and stability over time.
A process risk analysis is also carried out, using tools such as FMEA to identify critical points and control them right from the design stage.
Med'In QARA also helps you select laboratories, and manage and monitor tests to guarantee the quality of tests carried out externally. If validation testing is involved, Med'In QARA can help you validate your methods, an essential preliminary step.
Finally, a reconciliation with the device 's Device Master Record (DMR) is performed to confirm that the processes and software are fully integrated and comply with established safety and performance criteria.
Validation of your non-verifiable processes (formerly "special processes")
Packaging validation
Packaging validation is essential to guarantee the integrity of the packaging, and in particular the Sterile Barrier System, and the sterility of medical devices. This validation is carried out in accordance with ISO 11607-1 and -2 standards, to ensure that the packaging meets the performance and safety requirements.
Validation of sterilization processes
Medical device sterilization processes are validated in accordance with ISO 14937 (general standard), ISO 11135 (Ethylene Oxide sterilization), ISO 11137 (irradiation sterilization) and ISO 17665 (moist heat sterilization), to guarantee a product free from viable micro-organisms.
Aseptic process validation
For devices requiring an aseptic environment, aseptic treatment processes are validated in accordance with ISO 13408 series standards, ensuring contamination control and device safety throughout the manufacturing process.
Your software
The validation of software used in manufacturing and control processes is essential to ensure the reliability of processes and the safety of medical devices.
This is carried out in accordance with theISO/TR 80002-2 guidelines and the GAMP 5 guide, the real bibles for ensuring that your software complies with regulatory requirements.
Control of the environment and cleanliness
Qualification and validation of cleanrooms and controlled environments
Controlling production environments is crucial to the cleanliness and sterility of medical devices.
Qualification and validation of cleanrooms and controlled environments are carried out in accordance with the ISO 14644 standards to guarantee optimum production conditions.
Biocontamination control
In medical device production environments, biocontamination control is a priority.
Validation of biocontamination according to the ISO 11737 series of standards, and the implementation of rigorous routine monitoring in compliance with EN 17141, ensure a safe manufacturing environment.
Cleaning process validation
Device and equipment cleaning processes are validated to eliminate any potentially contaminating residues.
This validation is carried out using ISO 19227 and ASTM F3127 standards, guaranteeing the cleanliness and safety of the devices.
Key benefits
These sections provide a structured overview of the support offered by Med'In QARA. With this approach, I provide comprehensive and rigorous support for the validation of your processes, software and working environment, enabling you to meet the requirements of regulatory bodies with confidence.
©2024 Med'In QARA - Consulting and Assistance in Quality and Regulatory Affairs for the Medical Industry
Site design and referencing by
