Equipment validation is particularly vital in medical device industry in manufacturing and testing processes. Equipment used in any production requires qualification and verification. ADB is well equipped with certified professionals with many years of expertise specific to equipment validation projects.
We are thorough in our validation services and ensure the equipment is skillfully validated considering quality parameters to ensure safe and reliable results. ADB validation consultants can assist you with equipment design, its review, selection and installation. We are focused on minimizing failures and ensuring the equipment run reliably and consistently.
Here are the deliverables of our equipment validation projects
- Master plan for validation project documenting the project procedure in line with the regulatory standards
- Functional and user specification
- Risk Assessment – this is essential in validation processes and our services in risk-based validation include: identifying risks in the processes and equipment; impact of failure assessment; and determining the likelihood of risks occurring. A matrix document is derived from the risk assessment indicating the recommended level of qualification
- Authoring test case protocols
- Protocol execution: installation qualification; operation qualification; and performance qualification and qualification reports
- Change control management
- Preventive maintenance schedules