BioBoston Consulting: One Stop Solution for Life Sciences
What Is Computer System Validation (CSV)?
Computer System Validation (CSV) is the formal, documented process used in regulated industries—like pharmaceuticals and biotechnology—to ensure computerized systems consistently perform their intended functions accurately, reliably, and in compliance with regulatory standards such as FDA 21 CFR Part 11 and EU Annex 11. The process spans the system lifecycle, from planning and risk assessment through testing (IQ/OQ/PQ), change control, and retirement.
At BioBoston Consulting, CSV services include:
- CSV planning and protocol development
- Risk-based validation strategy
- Installation, operational, and performance qualification (IQ/OQ/PQ)
- Data integrity and security assurance
- Change control and revalidation processes
- Thorough documentation and reporting to support audits and inspections
Why CSV Is Essential for Life Sciences Clients
- Regulatory Compliance
Ensures adherence to FDA, EMA, MHRA, and other regulatory requirements for computerized systems in manufacturing, data handling, or quality operations. - Data Integrity, Reliability & Security
Validated systems maintain accurate, secure data—including controls over access and change history—to build trustworthy, auditable records. - Risk Mitigation
Validates systems proportionate to their criticality, reducing risks of data errors, batch failures, patient safety issues, or regulatory enforcement. - Audit & Inspection Readiness
Robust documentation and validation evidence support readiness for regulatory review at any time.
How Clients Benefit from BioBoston’s CSV Services
- Tailored, Risk-Based Strategies
BioBoston aligns validation effort with system criticality to optimize resource allocation while maintaining compliance. - Comprehensive Lifecycle Support
From initial planning to change management and revalidation, they cover every phase of the system’s life. - Expert Protocol Execution
BioBoston leads structured IQ/OQ/PQ testing, documenting each stage comprehensively to validate performance. - Strong Data Integrity & Change Control
They implement robust controls to guard data accuracy and manage system modifications effectively. - Deep Regulatory Alignment
Expertise across multiple regions ensures your systems meet global CSV expectations.
Who’s Responsible for CSV Services?
BioBoston’s Regulatory Affairs, Quality Assurance & IT Teams—comprising CSV specialists, QA professionals, system owners, and regulatory strategists—lead these validation efforts. They collaborate closely with your internal Quality, IT, and Operations teams to ensure seamless implementation.
At BioBoston Consulting—One Stop Solution for Life Sciences, we ensure your computerized systems are steadfast, validated, and regulatory-ready. Whether you’re implementing a LIMS, ERP, or clinical data system, our CSV experts bring rigor, clarity, and assurance.
Contact us today to talk CSV strategy and make your systems a pillar of quality and compliance.