Cleaning and Cleaning Validation has increasingly become a focus for FDA auditors. The FDA expects that regulated companies will have:
- Written general procedures on how cleaning processes will be validated.
- General validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required.
- Specific written validation protocols in advance for the studies to be performed on each manufacturing system or piece of equipment that address such issues as sampling procedures and analytical methods to be used including the sensitivity of those methods.
- A final validation report which is approved by management and which states whether or not the cleaning process is valid. The data should support a conclusion that residues have been reduced to an "acceptable level."
Cleaning Validation Services
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.
Ofni Systems uses FastVal to write validation documentation and execute Testing Protocols, which allows us to complete validation projects in 70% less time than traditional validation methods, with more time spent testing your software 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.
How can Ofni Systems help you?
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Ofni Systems can validate all of your systems. We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package to reviewing your quality system to ensure that you have a compliant cleaning program.
Cleaning Validation Methodology
Our validation experts will examine your equipment to determine the best approach. We will determine the best testing methodology and document cleaning requirements and testing limits. The analytical methods and sampling techniques, such as direct surface sampling or rinse sampling, that will be utilized are documented into appropriate functional and design requirements.
Once requirements have been outline and documented, test plans are developed to demonstrate that all the cleaning process meets the defined requirements. Our validation professionals will document a testing protocol, designed to demonstrate that your process meets all of your business requirements, plus regulatory requirements outlined by 21 CFR Part 820. As appropriate, this includes operational qualifications (OQ) and performance qualifications (PQ). Deviations, if they exist, will be reported and resolved.
Throughout the process, a Traceability Matrix is updated to ensure that all system requirements are addressed. If necessary, a formal risk assessment can be created to document decisions to focus validation testing. A Summary Report is also created at the end of the process to summarize any issues found during the validation project.
Additional Resources
Additional information is available on validation for specific types of computer systems.
Key Benefits of Using Ofni Systems Validation
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