• COMPUTER SYSTEMS VALIDATION PRACTICE

    RCM has a team of validation experts with comprehensive knowledge of FDA validation requirements. Well-versed in the specific requirements of pharmaceutical and medical device compliance, RCM Technologies personnel are completely knowledgeable with pharmaceutical and medical device processes. We supply full cGMP documentation packages and periodic re-qualification to meet strict FDA standards. Our experienced validation team will write clear, concise documents and implement IQ/OQ/ PQ protocols for QAD as well as specialized equipment qualifications to ensure compliance requirements.

    All of our validation services are thoroughly documented and are methodically reviewed before being released to the customer.

    Our complete turnkey services include: 

    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
    • Performance Qualification (PQ)
    • Summary Reports
    • Standard Operating Procedures (SOP)
    • GAP Analysis
    • Preventive and Corrective Maintenance
    • Calibration

    All of our documents are written to ensure compliance with your internal Quality Assurance personnel as well as cGMP and FDA requirements. We provide comprehensive IQ/OQ/PQ support for all phases of the FDA-approval process and revalidation services are available to assure continued compliance.

     

     

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