KOROS offers a full range of Quality and GxP services to support your business from the development to post-market surveillance phases. Our team of experts have worked across all aspects of Quality and Regulatory compliance for clients from across the globe.
Their depth and range of experience spans all sectors of the life sciences industry. We will partner with you to provide tailored services, flexible budgeting, and a team of consummate professionals. As your partner, we will create a customized and comprehensive plan to meet your company’s specific requirements.
Consulting Services
- Gap Assessments
- Quality Management Systems
- Risk Assessment and Management
- Inspection Readiness
- On-Site Audit Support
- Real World Evidence
- System Implementation
GxP Support:
- Documentation Support
- Training and Education
- Investigation and Corrective Action
- Deviation Management
- Monitoring and Oversight
- Quality Roadmap/Storyboard
Training Support:
- BIMO: Bioresearch Monitoring
- Staying Ahead of the Curve: Regulatory Updates for Life Science Professionals
- Inspection Readiness: A Survival Guide
- Risk Mitigation Strategies
- Data Integrity: The Cornerstone of Quality
- Communicating with Clarity
GxP Validation Services
KOROS also offers comprehensive technology support services that are designed to meet your specific needs and priorities. Our experienced team leverages a risk-based approach to ensure that your systems are optimized for efficiency, compliance, and performance.
With a deep understanding of life sciences software and systems, we provide expert support that helps you navigate the complexities of modern regulations. Our IT & CSV Services Validation ensures that your computer systems meet the stringent requirements outlined in current regulations, delivering reliable and accurate results that align with your specifications and quality standards.
GAP Assessment
- User Requirement Specifications
- Validation Report
- Traceability Matrix development
- Functional Requirement Specifications
- System Risk and Regulatory Applicability Assessment
- Installation Qualification (IQ) Scripts and Results
Validation plan
- System Architecture Design
- Hypercare Solutions
- System Release Documentation
- Network and Infrastructure Qualification
- Operational Qualification (OQ) Scripts and Results
- Performance Qualification (PQ) Scripts and Results