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ERP REGULATORY COMPLIANCE


The Kymanox Intelligent Enterprise Team is an international provider of ERP compliance (e.g., FDA, EMA) solutions for life sciences. As pragmatic client advocates, we offer a patient-centric, risk-based approach balanced with both regulatory requirements and business needs.

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Improved Regulatory Agency Interactions


The Kymanox Intelligent Enterprise Team includes former government regulatory personnel, healthcare and life science Subject Matter Experts (SMEs), IT and MIS professionals, and ERP implementation specialists who eliminate the ambiguity surrounding regulations and quality assurance requirements. We generate clear and well-documented project plans that address the requirements set forth by the regulatory bodies (e.g., FDA, EMA). Clients who partner with us experience more efficient, productive, and confident interactions with regulatory reviewers and auditors.



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    ENTERPRISE VALIDATION AND CGMP/CGxP COMPLIANCE SERVICES


    By leveraging Kymanox project accelerators, we are able to rapidly complete your enterprise compliance initiative with industry-proven policies, procedures, and templates. Additionally, our Computer System Validation (CSV) Toolkit, as available at www.KymanoxWORKS.com, is universal and may be employed throughout the lifecycle of your ERP engagement or at select phases on the implementation road map that require tactical support and troubleshooting.

    Kymanox provides expertise for ERP systems in the following areas:

      • SAP, Sage, MS Dynamics, ASC, and Oracle (i.e., JD Edwards, NetSuite)

      • Custom Planning and Reporting

      • User and Configuration Specification Development

      • Data Integrity and Part 11 Compliance

      • Implementation, Change Management, and Training

      • Validation Project Planning

      • CGxP Risk Assessments

      • Audit Trail

      • System and Product Lifecycle Management

      • Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Development

      • Data Migration Planning

      • Computer System Validation (CSV)

      • Trace Matrix Development to Map Testing and Requirements

      • Good Documentation Practices

      • Audit- and Submission-Ready Summary Reports

      QUALITY BY DESIGN (QbD) AND PATIENT CENTRICITY


      Our overall approach to providing solutions is based upon the principles of Quality by Design (QbD) and Patient Centricity. We leverage practical experience in life sciences, understanding of patient safety, expert planning, and sound engineering. We utilize Ideal Knowledge Transfer™ (IKT™), risk management, data integrity, and professional project management to ensure our ERP Regulatory Compliance Solutions are unmatched in quality and value.

      YOUR LIFE SCIENCE SOLUTIONS PARTNER FOR ERP SOFTWARE VALIDATION AND CGxP COMPLIANCE

      Biotechnology | Pharmaceuticals | Medical Devices | Combination Products