Computer System Validation (CSV)

Kymanox offers expertise in implementing comprehensive support for selection, implementation, and validation of computerized systems including ERP, MES, BMS, EMS, CMMS, and SCADA systems.

Our services support all Life Science organizations in biotechnology, pharmaceutical, and medical device manufacturing. Our Subject Matter Experts (SMEs) help ensure successful implementations and compliance with 21 CFR Part 11 and data integrity regulations.

  • Specification Development
  • System Selection and Vendor Management
  • Hardware and Software Implementation
  • System Configuration
  • Development of Procedures
  • Computer System Validation Solutions
  • System Training and Administration through Handoff
  • Computer System Validation (CSV) Capabilities

    Kymanox® experts have developed a suite of procedures and templates that accelerate our ability to implement a comprehensive CSV program within any life science organization.
    01

    On-Site and Off-Site Support  

    We perform gap and risk assessments of the software, infrastructure, and IT services your business relies on, whether on-site or off-site. We can also assess other quality system elements like training and SOPs.
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    02

    Quality Audits  

    Kymanox offers third-party supplier audits to evaluate the capabilities and quality systems of a prospective vendor, as well as response audits when there are concerns with the performance of a purchased product.
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    03

    Specialized Software Support  

    When you need specialized support, we can provide CSV support for graphics software used in devices and manufacturing, clinical databases and spreadsheet software, and cloud-based REMS applications.
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    04

    Documentation for CSV and Data Integrity

    Kymanox has extensive experience in developing documentation to address 21 CFR Part 11 compliance and data integrity regulations.
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    What Our Clients Have To Say About Kymanox

    “They go above and beyond to collaborate with us”
    LYNN DAWSON
    VALIDATION CORPORATE DIRECTOR AT MEDICAGO
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    "Other companies don't follow through the way Kymanox does"
    MATT WHEELER
    ASSOCIATE DIRECTOR, VALIDATION AT PRECISION BIOSCIENCES
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    "The team was responsive, adaptable, very communicative, and willing to do whatever we asked."
    WILLIAM BOHNAKER
    DIRECTOR OF OPERATIONAL EXCELLENCE AT A RAPIDLY GROWING BIOPHARMACEUTICAL COMPANY
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