Kruse Integration has been providing validated automation systems for the pharmaceutical and biotechnology industries for years. Our automation systems typically utilize programmable logic controllers (PLCs) for logic control. We have, however, utilized direct PC control when requested by the customer and where it made sense. Our systems often utilize human-machine interface (HMI) products to provide operators with control and monitoring capabilities. We have designed automation systems for a diverse group of applications, including:
Where dynamic batch recipe control and extensive batch archiving were required, we have provided ISA S88 compliant batching systems using off-the-shelf products customized for the specific application.
Where data acquisition and storage were required, we provided database servers and I/O structures to gather process information and store it in reliable and efficient tables. Automatic report generation via printers, email or intranet is provided when required.
At Kruse Integration, we are familiar with the cGMP guidelines required for FDA validation. Our design and implementation process allows us to provide well-documented systems that can be easily validated for the FDA. We have passed customer audits that examined our design and documentation procedures to help ensure future validation success.
The recent FDA emphasis on 21 CFR Part 11 compliance places a premium on companies with control, data handling and validation compliance experience. Kruse Integration is experienced in all these areas and has helped several customers meet 21 CFR Part 11 compliance. Kruse Integration can provide 21 CFR Part 11 compliance audits, recommend and implement 21 CFR Part 11 compliance strategies and provide validation for 21 CFR Part 11 compliant systems.
Part 11 Compliance Auditing: Computer System Assessment • Infrastructure Assessment (Network Topology) • Plant Floor Automation Systems Assessment • Software Assessment • Code and Documentation Assessment
Part 11 Compliance Strategies: Develop In House Compliance Team • Training on Part 11 • Define Critical Operations and Associated Systems • Develop In House Standards (Consider Corporate Global Harmony) • Develop a Compliance Plan
Part 11 System Development (Life Cycle Methodology): System Replacement or Remediation? • Develop User Requirements • Develop Functional Specs • Audit Potential Vendors • Select Hardware and Software • Develop Traceability Matrix
Project Implementation (Life Cycle Methodology): Design Based on Functional Spec and GxP • Design Review • Implement Design following GMP • Functional Testing • Stress Testing • Software and Hardware Maintenance Documents • User’s Manual • Qualification and Validation • Training
Part 11 Additional Services: Change Control Computer and PLC Programming • Calibration, Testing and Software/Hardware Validation • Spreadsheet and Macro Part 11 Compliance Development • Traceability Matrix Development (Verifies system conforms to User and Functional Specs)
Whether you require validated full-scale production automation, validated data collection or 21 CFR Part 11 expertise, Kruse Integration can be your sole source solution.