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  • Product
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      • Modules
        • Overview An overview of ValGenesis's Validation Lifecycle Management System (VLMS)
        • GxP Assets Management Manage the lifecycle of GxP assets with a documented audit trail
        • Validation Plan &
          Framework Maintain a consistent approach across all validation processes and sites
        • Validation
          Projects Manage complex validation projects with required quality gate checks
        • Requirements Management Manage change requirements as a closed loop validation process
        • Document Lifecycle Management Track documentation from design to change management and validation
        • Dynamic Trace
          Matrix Identify and fix defects related to important requirements
        • Electronic Test Case Execution Execute test cases quickly and securely, anywhere at any time
        • Robotic Test Case Execution Reduce execution time by up to 90% by removing human errors
        • Periodic Review Management Identify and manage the review schedules of validated GxP systems
        • Risk-Based Validation Evaluate and control risk at functional and/or system levels
        • Change Control & Management Track and efficiently manage any type of change request
        • Equipment Log Management Record, verify, and review logs as per approved SOPs/standards
        • Retirement & Decommissioning Process Plan and execute the entire process with required quality gate checks
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  • Solutions
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      • Solutions
        • Overview An overview of ValGenesis's Paperless Validation Software Solutions
        • Computer Systems Validation Error-free, paperless, fully automated lifecycle management process
        • Equipment & Instruments Validation Quick access to data and validated state of equipment
        • Cleaning Validation Integrated, seamless lifecycle process across multiple groups and sites
        • Analytical Method Validation Error-free, paperless, integrated analytical method lifecycle validation
        • Process Validation Seamless connectivity across process, data, and knowledge management
        • Facility Commissioning & Qualification Risk-based commissioning and qualification process
        • Cold Chain Validation IoT capable validation for temperature controlled supply chains
        • eLog Book Verification and review (with e-signature) of equipment logs at point-of-need
        • VConnect – SDMS Data captured from equipment is plugged into all documentation/evidence
        • Validation Centric ALM Accommodate every change while maintaining validated status
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  • Services
  • Platforms
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      • Platforms
        • Technology Addressing critical technology elements for any life science enterprise
        • SaaS Manage critical validation, quality/regulated data and documents in the secured cloud
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  • Compliance
  • Industries
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      • Industries
        • Blood & Tissue Consistently meet Blood Establishment Computer Software (BECS) Requirements
        • Contract Organizations Enforce approved validation plans to be audit-ready without preparation
        • GxP Laboratories Ensure data integrity and get organized with automated audit trails
        • Medical Devices Seamlessly manage Design History Files (DHF) across all units and sites
        • Nutraceutical Single environment requirements management, simplifying proof of compliance
        • Pharma/Biotech Achieve standardization and data integrity via seamless processes
        • Regulated Software Companies Quickly release new versions/ service packs with our test automation engines
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  • Resources
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      • Resources
        • Overview A quick snapshot of our library of resources
        • Press Releases Check for the latest information from our newsroom
        • Blogs Stay informed and up to date on hot topics and current events
        • Webinars Access our library of on-demand webinars
        • Events Check the calendar of events we are attending this year
        • Client Stories See what clients say about our suite of validation services and solutions
        • White Papers Access our library of educational white papers
        • Videos Access our library of educational videos on validation
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  • Meet ValGenesis
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      • Meet ValGenesis
        • About Us A global organization established in 2005 in South San Francisco, CA
        • Clients Working with life science organizations, including several Fortune 500 companies
        • Partners Building on the strengths of partners to add significant value to services and solutions
        • Contact Us Wide support network to assist clients across the globe
        • Careers A talented, well qualified team - the backbone of our success
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  • Product
    • Overview
    • GxP Assets Management
    • Validation Plan & Framework
    • Validation Projects
    • Requirements Management
    • Document Lifecycle Management
    • Dynamic Trace Matrix
    • Electronic Test Case Execution
    • Risk-Based Validation
    • Robotic Test Case Execution
    • Periodic Review Management
    • Change Control & Management
    • Equipment Log Management
    • Retirement & Decommissioning Process
  • Solutions
    • Overview
    • Computer Systems Validation
    • Process Validation
    • VConnect – SDMS
    • Equipment & Instruments Qualification
    • Facility Commissioning & Qualification
    • Validation Centric ALM
    • Cleaning Validation
    • Cold Chain Validation
    • Analytical Method Validation
    • eLog Book
  • Services
  • Platforms
    • Technology
    • SaaS
  • Compliance
  • Industries
    • Blood & Tissue
    • Nutraceutical
    • Contract Organizations
    • Pharma/Biotech
    • GxP Laboratories
    • Regulated Software Companies
    • Medical Devices
  • Resources
    • Overview
    • Press Releases
    • Blogs
    • Webinars
    • Events
    • Client Stories
    • White Papers
    • Videos
  • Meet ValGenesis
    • About us
    • Clients
    • Partners
    • Contact Us
    • Careers
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RESOURCES / Blogs

Blogs

Recent Posts

Digitization of Validation for Effective Off-site Regulatory “Review” and “Inspection”
Hands-Free Validation
FDAs Computer Software Assurance (CSA) – Part 3 of 3
Business Continuity Plan (BCP) for Validation Program amid a Pandemic
The Business and Buzz of IoT
FDAs Computer Software Assurance (CSA) – Part 2 of 3
FDAs Computer Software Assurance (CSA) – Part 1 of 3
Why Validation projects fail
Digital Transformation/Pharma 4.0: Impressive technology, but what about people?
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Recent Posts

  • Digitization of Validation for Effective Off-site Regulatory “Review” and “Inspection”
  • Hands-Free Validation
  • FDAs Computer Software Assurance (CSA) – Part 3 of 3
  • Business Continuity Plan (BCP) for Validation Program amid a Pandemic

Categories

  • Data Security (1)
  • Steve Thompson (1)
  • Types of Validation (1)
  • Validation (17)
  • Compliance (4)
  • Data Integrity (5)
  • Industry (10)
  • Pharma (2)
Locations
  • California

    395 Oyster Point Boulevard,
    Suite 228, South San Francisco,
    California 94080, USA

  • Florida

    4211 West Boy Scout Boulevard
    Suite 160, Tampa,
    Florida 33607, USA

  • Netherlands

    ValGenesis EMEA B.V.
    Evert van de Beekstraat 1-104
    1118 CL Schiphol
    The Netherlands

  • Germany

    ValGenesis EMEA B.V.
    Neue Messe Riem
    Kronstadter Strasse 4
    81677 München Germany

  • India

    705 - 708, 7th Floor, Phase II,
    TICEL Bio Park Limited,
    CSIR Road, Taramani,
    Chennai – 600113, TN

  • Ontario

    2000 Argentia Rd Suite 220
    Mississauga,
    Ontario L5N 1W1, Canada

Contacts
  • Sales & Demo Enquiries

    sales@valgenesis.com

  • General Information

    info@valgenesis.com

  • Support

    support@valgenesis.com

  • Career

    hr@valgenesis.com

  • Partnership

    partners@valgenesis.com

  • Privacy

    privacy@valgenesis.com

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