DATA INTEGRIDY MADE EASY
Validated. Compliant. Traceable. Audit-Ready
EasyMatch® Essentials L2-ER is HunterLab's validated electronic records platform for secure, compliant, and fully traceable color measurement. Designed for use with HunterLab L2 instruments, it supports both standalone instrument operation and enterprise deployment through HunterLab EasyMatch® Quality Central, providing a scalable solution for regulated laboratories and manufacturing environments.
The software helps organizations meet the electronic records and data integrity requirements of FDA 21 CFR Part 11, EU Annex 11, USP Analytical Instrument Qualification (AIQ), GMP, and ISO 17025 by providing secure user authentication, electronic records, audit trails, role-based access control, and complete measurement traceability.
Every measurement is automatically linked to the user, instrument serial number, calibration reference, date, and time, creating a permanent electronic audit trail that supports audit readiness and regulatory compliance. Data can be securely reviewed, exported, archived, and integrated with enterprise systems such as LIMS, SPC, and MES.
EasyMatch® Essentials L2-ER also includes configurable data views, pass/fail evaluations, HDMI display support for collaborative review, and secure enterprise connectivity while maintaining the simplicity of stand-alone instrument operation.
Validation and Compliance Notebook
Each EasyMatch® Essentials L2-ER system includes HunterLab's Validation and Compliance Notebook, a printable PDF that provides documentation and guidance for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
The notebook contains:
- System Validation Checklist
- Installation Qualification (IQ) Checklist
- Operational Qualification (OQ) Checklist
- Performance Qualification (PQ) Guidance
- Software Validation Statement
- ISO Certifications
- Regulatory Compliance Documentation
These documents assist customers in qualifying both the instrument and software for regulated environments while supporting internal validation procedures.
Installation Qualification (IQ)
Installation Qualification verifies that the instrument and software have been correctly installed and configured according to HunterLab specifications.
The IQ documentation includes:
- System overview
- Hardware and software requirements
- Installation procedures
- Required reference documentation
- Installation verification checklist
- Qualification statement
- Approval and sign-off documentation
Successful completion of IQ confirms that the system has been installed correctly and is ready for operational testing.
Operational Qualification (OQ)
Operational Qualification demonstrates that the instrument operates within HunterLab performance specifications.
The OQ protocol includes diagnostic testing such as:
- Wavelength accuracy verification
- Short-term repeatability testing
- Mid-range reflectance verification (Green Tile)
- Instrument operational checks
- Qualification statement
- Approval and sign-off documentation
Completion of OQ verifies that the instrument functions correctly and meets published performance specifications.
Performance Qualification (PQ)
Performance Qualification verifies that the instrument consistently performs as intended using the customer's routine measurement methods, accessories, standards, and production samples.
PQ documentation includes:
- Measurement method verification
- Application-specific testing
- Routine accessory verification
- Qualification statement
- Approval and sign-off documentation
Performance Qualification demonstrates that the complete measurement system performs reliably under normal operating conditions.
Data Integrity and Regulatory Compliance
EasyMatch® Essentials L2-ER incorporates numerous technical controls that support regulatory compliance and electronic record integrity, including:
- Secure user authentication
- Role-based access control
- Electronic audit trails
- Electronic record protection
- Automatic date and time stamping
- Instrument identification
- Calibration traceability
- Electronic signature support
- Tamper detection for modified job files
- Secure database storage
- Export to PDF, CSV, and XLSX formats
These features help ensure measurement records remain secure, traceable, and suitable for regulatory inspection.
IT Responsibilities During Installation and Validation
Successful implementation of EasyMatch® Essentials L2-ER requires collaboration between Quality Assurance, laboratory personnel, and the organization's Information Technology (IT) department.
While HunterLab provides the validated software platform and qualification documentation, customers are responsible for implementing the procedural controls required by FDA 21 CFR Part 11 and other applicable regulations.
Typical IT responsibilities include:
- User account creation and management
- Password policy implementation
- Network security configuration
- Audit trail management
- Database backup procedures
- Disaster recovery planning
- Data retention policies
- Integration with enterprise systems such as LIMS, SPC, and MES
- Support for software updates and validation documentation
- User training
- Identity verification
- Electronic signature usage
- Backup and recovery procedures
- Record retention
- Periodic system review
EasyMatch® Essentials L2-ER automatically detects and reports unauthorized modification of job files, helping protect electronic records and maintain data integrity throughout the validation lifecycle.
Summary
EasyMatch® Essentials L2-ER provides a validated electronic records platform that simplifies instrument qualification while supporting regulatory compliance and long-term data integrity. Combined with the Validation and Compliance Notebook, the software provides comprehensive documentation for IQ, OQ, and PQ activities, enabling organizations to efficiently qualify HunterLab instruments and maintain audit-ready operation throughout the system lifecycle.
Would you like to learn more? Contact us and we'll help you find the best solution for your needs.
For support related questions, submit a support ticket and one of our technical support engineers will contact you as soon as possible!
To learn more about Color and Color Science in industrial QC applications, click here: Fundamentals of Color and Appearance