Cleaning processes have increasingly become a focus for FDA auditors. Cleaning validation is required to document that cleaning processes function as expected. The FDA expects that regulated companies will have:
Ofni Systems validation specialists have experience working within the compliance requirements of established regulated companies. Our specialists are experts in industry validation standards and will produce validation documents which will meet or exceed your exacting standards.
How can Ofni Systems help you?
Ofni Systems uses FastVal to write cleaning validation documentation, which allows us to complete validation projects in 70% less time than traditional documentation methods, allowing for more time in production and less time preparing documentation. Our goal in all cleaning validations is to improve the quality and value of your process while ensuring your customers’ safety and your compliance with all applicable regulations.
Ofni Systems can validate all of your systems. We can provide any level of service required, from validating test methods to automating cleaning validation reports to reviewing your quality system to ensure that you have a compliant cleaning program.
Our validation experts will incorporate your cleaning protocols, SOPs, and methods into a suite of custom templates that allow for quick execution and turn-around of the cleaning validation.
Cleaning studies are initiated with the creation of a cleaning validation plan, complete with scheduling, role assignment, email notifications, and project tracking.
After a cleaning protocol is executed and cleaning samples analyzed, a cleaning validation report is generated to document that the cleaning process meets the defined requirements. Our cleaning validation documents are designed to demonstrate that your process meets all of your business requirements, plus regulatory requirements. All supporting reference material and documentation, including raw data and deviations, are linked via the FastVal system.
Finally, Quality Control review of the cleaning validation and report is documented, step by step, ensuring compliance and reporting accuracy.
Throughout the process, a Traceability Matrix is updated to ensure that all validation requirements are addressed. If necessary, a formal risk assessment can be created to identify areas for improvement.
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