Traceability and Chain of Custody
Establish traceability and maintain the chain of custody for samples, ensuring data integrity and credibility.
Document Management
Streamline document management and compliance with GLP, GCP, ISO 17025, GMP, HIPAA, ICH, and CFR.
Ensure employees are trained on safety practices and quality procedures, including when controlled docs are revised.
Revision Control
Ensure all docs and specs have proper documentation, review, and approval of changes & revisions by the right people.
Risk Management
Identify, assess, and manage risks associated with research projects, ensuring effective risk mitigation and compliance with regulatory requirements in a CRO.
Electronic Batch Records
Create, review, and approve batch records for testing and manufacturing, integrating testing data and ensuring traceability in a CRO.
Change Control
Implement a structured change control process to manage and document changes to research protocols, procedures, or any other aspect impacting research processes in a CRO, ensuring proper evaluation, approval, and traceability.
Complaint Handling
Capture, document, and track customer complaints, initiate investigations, implement corrective actions, and analyze complaint trends.
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 in a CRO.
Audit Management
Prepare for and manage audits, ensuring compliance with applicable regulations and standards in a CRO.
Calibration & Maintenance
Manage the calibration and maintenance schedules for equipment, track maintenance activities, and ensure compliance with calibration requirements.
Approval Workflows
Implement approval workflows within the QMS that allow for electronic signatures in compliance with 21 CFR Part 11 requirements.
Regulatory & Compliance
Ensure adherence with regulatory requirements, manage compliance documentation, and track regulatory changes
Performance Metrics and Reporting
Provide visual dashboards and analytics, offering insights into lab performance, productivity, and quality metrics.
Security & Access Controls
Implement robust security measures to protect sensitive data, ensure user access controls, and maintain audit trails for system activities.
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.
Test Method Management
Centralize and manage test methods, ensuring version control, accessibility, and compliance with standards.
Sample and Test Request Tracking
Track sample and test requests from initiation to completion, ensuring proper prioritization and timely execution.
Test Plan Management
Efficiently create and manage test plans, ensuring compliance with ISO/IEC 17025 requirements and accurate test coverage.
Test Result Recording and Reporting
Record and report test results, generating comprehensive reports for clients and regulatory compliance.
Sample Storage and Tracking
Manage sample storage and track sample locations, ensuring proper organization and easy retrieval.
Method Validation and Verification
Manage the validation and verification of test methods, ensuring compliance with ISO/IEC 17025 requirements.
Traceability and Chain of Custody
Establish traceability and maintain the chain of custody for samples, ensuring data integrity and credibility.
CAPAs and NCs
Identify, document, and resolve non-conformities; implement corrective/preventive actions.
Environment, Health & Safety (EHS)
Track and manage safety incidents, risks, EH&S audits, regulatory compliance, environmental protection, etc.