Track and manage safety incidents, risks, EH&S audits, regulatory compliance, environmental protection, etc.

Identify, document, and resolve non-conformities; implement corrective/preventive actions.

Establish traceability and maintain the chain of custody for samples, ensuring data integrity and credibility.

Manage the validation and verification of test methods, ensuring compliance with ISO/IEC 17025 requirements.

Manage sample storage and track sample locations, ensuring proper organization and easy retrieval.

Record and report test results, generating comprehensive reports for clients and regulatory compliance.

Efficiently create and manage test plans, ensuring compliance with ISO/IEC 17025 requirements and accurate test coverage.

Track sample and test requests from initiation to completion, ensuring proper prioritization and timely execution.

Centralize and manage test methods, ensuring version control, accessibility, and compliance with standards.

Integrate with other systems and tools, such as LIMS and CRM systems, and collaboration platforms to facilitate seamless information exchange and workflow management.

Implement robust security measures to protect sensitive data, ensure user access controls, and maintain audit trails for system activities.

Provide visual dashboards and analytics, offering insights into lab performance, productivity, and quality metrics.

Ensure adherence with regulatory requirements, manage compliance documentation, and track regulatory changes

Implement approval workflows within the QMS that allow for electronic signatures in compliance with 21 CFR Part 11 requirements.

Manage the calibration and maintenance schedules for equipment, track maintenance activities, and ensure compliance with calibration requirements.

Prepare for and manage audits, ensuring compliance with applicable regulations and standards in a CRO.

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.

Capture, document, and track customer complaints, initiate investigations, implement corrective actions, and analyze complaint trends.

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.

Create, review, and approve batch records for testing and manufacturing, integrating testing data and ensuring traceability in a CRO.

Identify, assess, and manage risks associated with research projects, ensuring effective risk mitigation and compliance with regulatory requirements in a CRO.

Ensure all docs and specs have proper documentation, review, and approval of changes & revisions by the right people.

Ensure employees are trained on safety practices and quality procedures, including when controlled docs are revised.

Streamline document management and compliance with GLP, GCP, ISO 17025, GMP, HIPAA, ICH, and CFR.

Establish traceability and maintain the chain of custody for samples, ensuring data integrity and credibility.