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COMPUTER SYSTEM VALIDATION


Kymanox has developed a suite of procedures and templates that provide a foundation for implementing a comprehensive Computer System Validation (CSV) program within a biotechnology, pharmaceutical, or medical device organization.


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Documentation for CSV and Data Integrity


Kymanox can provide expertise in developing the following documentation to address 21 CFR Part 11 compliance and data integrity regulations:

    • Validation Project Plans (VPPs)

    • Part 11, Gap, and Risk Assessments

    • User Requirements (URS), Software Requirements Specifications, Software Design Specifications

    • Traceability Analysis and Design Review

    • Commissioning Protocols, Validation Protocols
      (IQ/OQ/PQ), and Final Reports

    • Validation Monitoring, Exception Reporting, and Change Control

    Kymanox Expertise


    Kymanox has been an industry leader in CSV/Part 11 compliance for more than a decade. Kymanox was the first company to get a tablet application (i.e., iPad/iPhone app) approved by FDA for use in trauma surgery. Kymanox was one of the first companies to be involved in validating and remediating cloud-based applications used to make CGMP / GCP (i.e., manufacturing and clinical) decisions regulated by FDA and EMA. To date, Kymanox has validated over 100 major systems including patient portals for billion dollar drugs, electronic document systems, whole-enterprise systems (e.g., SAP), and high-risk medical device software. Our completed validation packages have been reviewed by countless external parties and regulatory bodies with no complaints or observations. Kymanox templates and procedures, as seen on www.KymanoxWORKS.com, are used by companies and regulatory bodies around the globe!

    Kymanox Expertise


    • Entire site and corporate gap assessments, and subsequent remediation, addressing all software and computer systems and potential CGxP impact.

    • SAP, Sage, MS Dynamics, JD Edwards, ASC, and other Enterprise Resource Planning (ERP) software including all modules impacting CGMP operations.

    • Commercial Off-the-Shelf (COTS) and custom software including Laboratory Information Management Systems (LIMS), Electronic Document Management Systems (EDMS), Electronic Quality Management Systems (QMS), Building Management Systems (BMS), Environmental Monitoring Systems (EMS), and complaint handling and related pharmacovigilance reporting systems.

    • Graphics software used in medical devices and CGMP manufacturing.

    • Clinical databases and spreadsheet software.

    • Cloud-based REMS applications governing black-boxed FDA medications.

    • Laboratory instruments and automated manufacturing and utility equipment using DCS, SCADA, PLC, and HMI.

    • Serialization systems per FDA Drug Supply Chain Security Act (DSCSA).

    Biotechnology | Pharmaceuticals | Medical Devices | Combination Products