OUR APPROACH

VALIDATION

Computer System Validation (CSV) is an absolute must where manufacturing automation is used in facilities required to meet FDA regulatory compliance. FDA requires the manufacturer have documented evidence that the automation systems perform as designed and as expected in a repeatable and predicable manner. The documentation to meet regulatory compliance is comprehensive and has no room for errors or ambiguities; rather it must be factual, concise and complete.

WHAT IS CSV?

Computer System Validation is the compilation of the plans, specifications, methods, data, testing procedures, testing forms and testing results to show evidence that a manufacturing automation system can consistently and repeatedly perform as designed and specified.

In CSV, we prove that your process control and data acquisition and reporting system is consistent and establish documentary evidence to show that your procedures, processes, and activities maintain compliance throughout production and system integration testing. If you operate in a regulated industry, such as pharmaceuticals or life sciences, we ensure that every aspect of your automation system is compliant with regulations. We minimize your risk through every stage of our work. And we use a proven process to meet validation requirements.

VALIDATION

Computer System Validation (CSV) is an absolute must where manufacturing automation is used in facilities required to meet FDA regulatory compliance. FDA requires the manufacturer have documented evidence that the automation systems perform as designed and as expected in a repeatable and predicable manner. The documentation to meet regulatory compliance is comprehensive and has no room for errors or ambiguities; rather it must be factual, concise and complete.

WHAT IS CSV?

Computer System Validation is the compilation of the plans, specifications, methods, data, testing procedures, testing forms and testing results to show evidence that a manufacturing automation system can consistently and repeatedly perform as designed and specified.

In CSV, we prove that your process control and data acquisition and reporting system is consistent and establish documentary evidence to show that your procedures, processes, and activities maintain compliance throughout production and system integration testing. If you operate in a regulated industry, such as pharmaceuticals or life sciences, we ensure that every aspect of your automation system is compliant with regulations. We minimize your risk through every stage of our work. And we use a proven process to meet validation requirements.

  • CSV Documentation

    CSV DOCUMENTATION

    anemptytextlline

    In the documentation step of validation, we provide thorough information about your system; how it was specified, the details, the operations, the testing and how it works. We put this information in the proper format to meet regulatory compliance for CSV thus mitigating your risk. Here’s where we cover everything related to CSV such as your Validation Master Plan, User Requirements Specification, Detail Design Specification, Standard Operating Procedures and various Protocols.

  • Execution

    EXECUTION

    anemptytextlline

    As we integrate your system and execute your project, we can create validation document seamlessly during every step of our work. If you have the team to execute validation protocols, we have all the knowledge to support your team and ensure a thorough and accurate validation initiative. We can even perform a gap analysis followed by a retrospective validation if you have an older automation system. In either case; new system or legacy system; we can help your meet regulatory requirements for CSV.

  • Electronic Records

    ELECTRONIC RECORDS

    anemptytextlline

    We can help you take your validation automation system to the next level of data reliability in a regulated environment by also designing your system to meet Title 21 CFR Part 11 for Electronic Records. Audit trails, absolute data integrity and data security are the cornerstones for meeting Part 11. We can help you with the technical considerations and deployments along with the SOPs and validation documents to support Part 11 compliance.

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