OUR APPROACH

EXECUTION

Through CSV documentation, we set you on the right course to ensure your system complies with FDA regulations. When we integrate your system, we also document every step of our work consistent with CSV. If you prefer to have your in-house team document and execute validation protocols, we can be right there with you, supporting your team to ensure a thorough and accurate validation. When your system is in place, we can help you place your automation system in full compliance with FDA regulations.

EXECUTION

Through CSV documentation, we set you on the right course to ensure your system complies with FDA regulations. When we integrate your system, we also document every step of our work consistent with CSV. If you prefer to have your in-house team document and execute validation protocols, we can be right there with you, supporting your team to ensure a thorough and accurate validation. When your system is in place, we can help you place your automation system in full compliance with FDA regulations.

PERFORM PROTOCOL EXECUTION

To validate your automation system, you are required to execute protocols for Installation Qualification (IQ), Operational Qualification (OQ) and, potentially, Performance Qualification (PQ). When we execute the IQ, OQ, and PQ, we go through every document and execute the test scripts while following the test plan to validate every portion of your automation system. We ensure that your system is completely tested, that you have documented evidence of the tests and that the CSV meets regulatory standards.

PERFORM VALIDATION SUPPORT

In some instances, we find that our customers employ a validation staff who are responsible for CSV within their facilities. We know how to support that sta. If your compliance team creates and executes the validation documents, we’re there to help assist them in any manner they need. Whether it’s our team or your team executing the protocols, we assist to assure that your system is thoroughly and accurately validated.

RETROSPECTIVE VALIDATION

We can perform a gap analysis followed by a retrospective validation for existing manufacturing automation systems that are already in operation but might not meet current FDA regulations for CSV. We might be able to use existing system documentation as a starting point for creating the other needed CSV documents. When we perform a retrospective validation we are very conscience of being fiscally responsible while helping you bring your automation system up to current regulatory compliance.

21 CFR PART 11 COMPLICANCE AND VALIDATION

Manufacturing automation systems that store data used to assess product quality and/or product integrity decisions within a facility under FDA compliance must meet Title 21 CFR Part 11 requirements for Electronic Records and Electronic Signatures. To comply with CFR Part 11, you need CSV documentation that clearly defines system operations and maintenance for unadulterated data integrity, data access and storage, physical and system security as well as audit trails and traceability.

At Malisko Engineering, we have the experience to help you create and execute a CSV plan that produces a comprehensive set of documented evidence demonstrating that your system meets 21 CFR Part 11.

GENERATE SUMMARY REPORTS

Validation Summary Reports provide an overview of your entire validation process. These reports include a description of your validation approach, a test definition, a record of tests, test results, test deviations and resolutions of those deviations, and a summary statement declaring that your system meets the defined requirements.

Once the system owner and other stakeholders identified in the Validation Master Plan review and sign the summary report, your validation project is complete. The finished package of validation documents is a CSV portfolio where we align every document to fit together so that the methods, details, execution steps and results flow in a logical fashion. Once our validation project is complete, you’ll have all validation packages stored according to your site document control procedures.

INDUSTRIAL AUTOMATION FOR RESULTS

In our more than 20 years of helping manufacturers, we’ve intelligently applied automation for hundreds of companies across a wide range of industries. And we’ve earned repeat business from 90 percent of our clients.

Have a question or do you want more output, fewer lost batches and better reports? We can show you how to improve your production and maximize your successes through industrial automation.

500 N BROADWAY SUITE 1600 ST LOUIS, MO 63102

(314) 621-2921

500 N BROADWAY
SUITE 1600
ST LOUIS, MO 63102

(314) 621-2921