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The purpose of this document is to present a structured, clause-by-clause explanation of FDA 21 CFR Part 11 requirements and to demonstrate how EasyMatch QC-ER satisfies those requirements. The included compliance table maps each regulatory provision directly to the corresponding EasyMatch QC-ER functionality, clearly identifying how the software supports electronic records and electronic signatures in regulated environments.

 

Important Notes:

Clause-by-Clause Regulatory Mapping

Each section of 21 CFR Part 11 is explicitly listed and paired with the corresponding EasyMatch QC-ER functionality, allowing users to clearly see how specific regulatory requirements are met.

Clear Identification of Compliance Mechanism

The table distinguishes between Technical controls built into the software (e.g., audit trails, login enforcement, signature locking) and Procedural controls that must be implemented by the user company.

Focused on Closed System Compliance

The compliance table addresses FDA Part 11 requirements as they apply to closed systems and explains how EasyMatch QC-ER supports authenticity, integrity, confidentiality (when appropriate), and non-repudiation of electronic records.

The attached document contains a detailed 21 CFR Part 11 compliance table that:

  • Lists each applicable subpart and requirement of the regulation
  • Describes the specific EasyMatch QC-ER feature or control that addresses the requirement
  • Identifies whether the compliance mechanism is Technical, Procedural, or a combination
  • The attached table explains how EasyMatch QC-ER supports key Part 11 elements including:
System validation support (IQ/OQ documentation and validation guidance)
  • Audit trails with secure, time-stamped records
  • Electronic signature controls and signature/record linkage
  • User authentication and password management
  • Access restrictions and authority checks
  • Tamper detection and data integrity protections
  • Record retention and retrieval capabilities

Through this structured mapping, the document provides a transparent demonstration of how EasyMatch QC-ER aligns with Part 11 expectations for closed systems.

This table is included in the HunterLab Validation & Compliance Notebook (PDF), provided with every EasyMatch QC-ER software package. The Validation & Compliance (V&C) Notebook is a comprehensive regulatory support resource designed to help customers confidently implement EasyMatch QC-ER in FDA-regulated environments (21 CFR Part 11), EU GMP Annex 11 (Computerized Systems), and other globally regulated markets that require validated electronic records and electronic signature controls.

It includes:

  • 21 CFR Part 11 Compliance Mapping – A clause-by-clause table explaining how EasyMatch QC-ER meets electronic records and electronic signature requirements.

  • System Security & Configuration Guidance – Windows security setup, user access controls, password policies, audit trail configuration, and system safeguards.

  • Complete Validation Support (IQ/OQ/PQ) – Installation Qualification, Operational Qualification, and Performance Qualification protocols for both software and supported instruments.

  • SOP & Compliance Documentation Guidance – Templates and guidance for user account management, identity verification, electronic signature policies, record retention, and FDA certification.

  • Audit-Ready Documentation – Checklists, validation statements, ISO certification references, training certificates, and supporting CFR documentation.

The V&C Notebook provides the documentation, protocols, and compliance framework needed to support FDA Part 11 validation, inspection readiness, and regulated deployment of EasyMatch QC-ER.

 

Do you need more information? Submit a ticket and a support team member will reach out to you soon!

To learn more about Color and Color Science in industrial QC applications, click here: Fundamentals of Color and Appearance

 

 

Keywords: EasyMatch QC-ER, EZMQC-ER, CFR 21 Compliance

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