The purpose of this document is to provide a clause-by-clause explanation of FDA 21 CFR Part 11 requirements and to demonstrate how EasyMatch® Essentials-ER software operating on Vista L2 satisfies those requirements. The compliance table maps each applicable regulation directly to the corresponding system functionality, clearly identifying whether compliance is achieved through technical controls within the system or through procedural controls implemented by the user company.
Important Notes:
Clause-by-Clause Regulatory Mapping
Each Part 11 requirement is explicitly listed and paired with the corresponding Vista Essentials-ER functionality, providing clear traceability between regulation and system capability.
Technical vs. Procedural Responsibilities Clearly Defined
The table distinguishes between built-in technical safeguards (audit trails, e-signature locking, role-based access, password controls) and procedural controls that must be established by the user company (SOPs, training, identity verification, certification to FDA).
Closed-System Compliance Framework
The document addresses 21 CFR Part 11 requirements as they apply to closed systems and demonstrates how Vista L2 with Essentials-ER supports authenticity, integrity, non-repudiation, and secure handling of electronic records.
This document contains a structured 21 CFR Part 11 compliance table specific to Vista L2 with EasyMatch Essentials-ER. It:
Lists each relevant subpart and requirement of Part 11
Describes how Vista Essentials-ER addresses each requirement
Identifies whether controls are Technical, Procedural, or a combination
Clarifies that compliance responsibility is shared between system capabilities and user SOPs
The table explains how the system supports:
Electronic records creation, storage, retrieval, and protection
Time-stamped audit trails
Electronic signature controls and permanent signature-to-record linkage
User authentication and role-based access control
Password management and login safeguards
System validation support (IQ/OQ/PQ guidance)
Record export and inspection readiness
It also clearly states that the system addresses closed systems under Part 11 and outlines user responsibilities for SOPs, identity verification, and FDA certification of electronic signatures.
This table is included in the HunterLab Validation & Compliance Notebook (PDF), provided with every Vista L2 instrument with EasyMatch Essentials-ER onboard software. The Validation & Compliance (V&C) Notebook is a comprehensive regulatory support resource designed to help customers confidently implement EasyMatch Essentials-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 Essentials L2-ER meets electronic records and electronic signature requirements.
System Security & Configuration Guidance – 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 Essentials L2-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