A ProPharma Group knowledge center & resource

+1 (847) 295-7160

View Cart Log In

Validation Center Logo
  • Validation
  • Compliance
  • Data Integrity
  • Training
  • Resources
  • Contact

Home / Library / Validation Templates and Software Quality SOPs / CSV Template – 21 CFR Part 11 Assessment

View Cart
validation template, FDA 21 CFR Part 11

CSV Template – 21 CFR Part 11 Assessment

$75.00

This 21 CFR Part 11 Assessment template has been designed to verify and document a system’s compliance with FDA 21 CFR Part 11.

Template includes a 37 question checklist. Each question is cross-referenced to a requirement within 21 CFR Part 11. The template also includes an example of a typical approach for assessing a system for Part 11 compliance.

SKU: 100001 Category: Validation Templates and Software Quality SOPs

You may also like…

  • Computer System Validation SOP

    SOP Computer System Validation

    Addresses the requirements for computer systems validation and includes sections on validation deliverables, roles and responsibilities, and quality assurance controls.

    $75.00
    Add to cart
  • Risk Based Validation SOP

    SOP System Risk-Based Validation

    Procedure for defining a validation approach based on the risk assessment and vendor audit. Includes details on the impact to validation testing and documentation.

    $75.00
    Add to cart
  • Template - Validation Summary Report

    Package – Validation Templates and Quality SOPs – Complete Package

    Get the complete package of 38 validation templates and quality assurance SOPs for $960.  A 60% savings over individual purchases.

    $960.00
    Add to cart

  • Don’t Miss Out

    Sign up to be the first to receive new computer system validation templates and SOPs, Free and Discounted Validation Templates.

  • FAQ

    How do I download a document?
    How do I access my documents?
    What is the document format?

    Get the Answers
  • Search the Library

    Find and download the latest FDA Warning Letters, Regulations, Guidelines, Templates, and SOPs.

    Everything Validation

    • Validation & Consulting Services
      • Validation Services
      • CSV & CSA Programs
      • Validation Process Improvement
      • Equipment, Facilities, Utilities Qualification
    • Compliance Services
      • Part 11 and Annex 11 Gap Assessments
      • Part 11 and Annex 11 Compliance
      • Compliance Verification Audits
      • IT Vendor Audits
    • Data Integrity Services
      • Data Integrity Gap Assessments
      • Data Integrity Policies and Procedures
      • Data Governance Programs
    • Validation, Compliance, and Data Integrity Training & Webinars
    • Validation & Quality Resources
    • Blog & News

    Validation Center

    Validation Center brings you all the resources needed for computer system validation. We provide one-stop access to validation experts, training, and tools.

    propharma logo

    About ProPharma

    For the last 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. With deep domain expertise in regulatory sciences, clinical research solutions, quality and compliance, pharmacovigilance, medical information, FSP solutions, and digital transformation, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. For more information about ProPharma, please visit www.propharmagroup.com.
    US & Canada | UK | Europe | APAC
    107 W Hargett St, Raleigh, NC 27601 | +1 (847) 295-7160

    Company

    • About Us
    • Our Instructors
    • Careers
    • News
    • Contact Us

    Stay Connected

    Be the first to know about upcoming classes and free webinars.


    • facebook
    • twitter
    • linkedin

    © 2026 ProPharma Group | Privacy Policy | Terms