CSV/CSA SERVICES

Consulting and Outsourcing

Your Trusted Partner in Computerized Systems/Software Compliance (CSV/CSA)

Our CSV/CSA consultants ensure that your systems are functional, validated, and audit-ready, reducing compliance risks and enhancing operational performance. Whether designing, validating, implementing, optimizing, reviewing, investigating, auditing, or providing remediation, PSC Biotech^® is your trusted partner in CSV/CSA compliance. Our team of seasoned professionals is ready to assist you in ensuring regulatory compliance and operational excellence. Contact us today to discuss your CSV/CSA needs and learn how our expertise can streamline your validation processes.

CSV/CSA Capabilities

CSV focuses on ensuring that software functions as intended and meets regulatory requirements using manual testing and compliance through documentation.

CSA adopts a risk-based approach to validating computerized systems using automated testing and modern software development methodologies.

Enterprise Systems

• Electronic Document Management Systems
• Clinical Data Systems
• Adverse Event Reporting Systems
• Manufacturing Execution Systems (MES)
• Enterprise Resource Planning (ERP)
• Quality Management Systems (QMS)

Laboratory Systems

• Laboratory Information Management System (LIMS)
• Facility & Equipment Management Software
• Material Requirements Planning (MRP) Systems
• Calibration Management Software Implementation & Validation
• Plant Maintenance Asset Management System Implementation & Validation
• Thermal Mapping & Environmental Monitoring Systems

General Services

• Data Integrity Compliance
• Test protocols - IQ/OQ/PQ/UAT
• Risk Management documents
• Requirement Specifications - SRS, FRS, Software Requirements
• Test Plan/Reports
• Traceability Matrix
• Data Migration Plan/Report
• Standard Operating Procedures - SOPs

LIFE SCIENCE EXPERTISE ON DEMAND

What makes PSC Biotech^® the partner of choice for leading life science companies? It’s our full-service approach to ensuring your facilities, equipment, and processes meet regulations set by leading regulatory bodies. Access the full spectrum of software and service solutions your company needs to thrive. Contact a PSC^® expert today.

CONTACT OUR EXPERTS