Track and manage safety incidents, risks, EH&S audits, regulatory compliance, environmental protection, etc.
CAPAs and NCs
Document, track and correct non-conformities & CAPAs to meet safety standards like 21 CFR Part 700, EU Cosmetics Regulation (EC No 1223/2009) and ISO 22716.
Environment, Health & Safety (EHS)
Track and manage safety incidents, risks, EH&S audits, regulatory compliance, environmental protection, etc.
CAPAs and NCs
Identify, document, and resolve non-conformities; implement corrective/preventive actions.
Change Control
Implement a structured change control process to manage and document changes to methods, equipment, procedures, ensuring proper evaluation, approval, and traceability.
Revision Control
Ensure all docs and specs have proper documentation, review, and approval of changes & revisions by the right people.
Method Validation and Verification
Manage the validation and verification of test methods, ensuring compliance with ISO/IEC 17025 requirements.
Sample Storage and Tracking
Manage sample storage and track sample locations, ensuring proper organization and easy retrieval.
Test Result Recording and Reporting
Record and report test results, generating comprehensive reports for clients and regulatory compliance.
Test Plan Management
Efficiently create and manage test plans, ensuring compliance with ISO/IEC 17025 requirements and accurate test coverage.
Sample and Test Request Tracking
Track sample and test requests from initiation to completion, ensuring proper prioritization and timely execution.
Test Method Management
Centralize and manage test methods, ensuring version control, accessibility, and compliance with standards.
Integration & Collaboration
Integrate with other systems and tools, such as LIMS and CRM systems, and collaboration platforms to facilitate seamless information exchange and workflow management.
Security & Access Controls
Implement robust security measures to protect sensitive data, ensure user access controls, and maintain audit trails for system activities.
Performance Metrics and Reporting
Provide visual dashboards and analytics, offering insights into lab performance, productivity, and quality metrics.
Regulatory & Compliance
Ensure adherence with regulatory requirements, manage compliance documentation, and track regulatory changes
Approval Workflows
Implement approval workflows within the QMS that allow for electronic signatures in compliance with 21 CFR Part 11 requirements.
Calibration & Maintenance
Manage the calibration and maintenance schedules for equipment, track maintenance activities, and ensure compliance with calibration requirements.
Audit Management
Plan, schedule, and conduct internal, layered and external audits for compliance verification.
Supplier Quality
Streamline supplier evaluation, qualification, and monitoring processes to ensure that suppliers meet the required quality standards, track supplier performance, and manage supplier-related non-conformances effectively.
Complaint Handling
Capture, document, and track customer complaints, initiate investigations, implement corrective actions, and analyze complaint trends.
Change Control
Implement a structured change control process to manage and document changes to test methods, equipment, procedures, or any other aspect impacting testing processes, ensuring proper evaluation, approval, and traceability.
Electronic Batch Records
Create, review, and approve batch records for testing and manufacturing, integrating testing data and ensuring traceability in a lab.
Risk Management
Identify, assess, and manage risks associated with testing processes, ensuring effective risk mitigation and compliance with ISO/IEC 17025 requirements.
Revision Control
Ensure all docs and specs have proper documentation, review, and approval of changes & revisions by the right people.
Training
Ensure employees are trained on safety practices and quality procedures, including when controlled docs are revised.
Document Management
Simplify ISO 17025 compliance with robust document management capabilities, ensuring traceability, version control, and easy access to critical records