Computer Systems Validation (CSV) Consulting
Sequence ensures that all computerized systems used in GMP-regulated pharmaceutical and biopharma processes are reliable, secure, and compliant. From FDA 21 CFR Part 11 to EU Annex 11, we verify data integrity, support product quality, and mitigate operational risks across the Research Triangle and nationwide.
Comprehensive Computer Systems Validation Expertise
Computer Systems Validation is critical for pharmaceutical and biotech companies to ensure their computerized systems consistently perform as intended while maintaining compliance with FDA 21 CFR Part 11 and global regulatory requirements.
Our team brings deep expertise in validating complex systems across the manufacturing lifecycle — from MES and LIMS to ERP and QMS platforms. We follow risk-based validation approaches aligned with GAMP 5 guidelines to deliver efficient, compliant, and scalable CSV solutions for life sciences manufacturers.
Combined with our CQV and engineering capabilities, Sequence provides a fully integrated approach to pharmaceutical compliance and system validation.
GMP Computerized Systems We Validate
Manufacturing Execution Systems (MES)
Complete validation of MES platforms that track and document pharmaceutical manufacturing processes, ensuring data integrity and regulatory compliance throughout production.
Control Systems (PLC/DCS)
Validation of physical sensors, transmitters, and control systems including monitoring, supervision, discrete control, continuous control, and batch control platforms in GMP environments.
Enterprise Resource Planning (ERP)
Validation of business planning and logistics systems that manage resources, financials, supply chain, and operational workflows across pharmaceutical enterprises.
Laboratory Information Management System (LIMS)
Comprehensive validation of LIMS platforms managing sample tracking, analytical testing, data management, and laboratory workflows for life sciences manufacturers.
Computerized Maintenance Management Systems (CMMS)
Validation of maintenance tracking systems ensuring equipment reliability, preventive maintenance scheduling, and asset management compliance in regulated facilities.
Quality Management Systems (QMS)
Validation of quality management platforms managing deviations, CAPAs, change control, document control, and quality event investigation processes for pharmaceutical operations.
Risk-Based Computer Systems Validation Excellence
Our Computer Systems Validation methodology follows GAMP 5 principles and FDA guidance, applying risk-based approaches to ensure efficient validation of pharmaceutical computerized systems without compromising compliance or quality.
- FDA 21 CFR Part 11 compliance expertise
- GAMP 5 category-based validation strategies
- EU Annex 11 alignment for global operations
- Data integrity (ALCOA+) verification
- Electronic signature and audit trail validation
- System lifecycle support and ongoing compliance
Ready to Validate Your Pharmaceutical Systems?
Partner with Sequence for comprehensive Computer Systems Validation (CSV) consulting that ensures compliance, data integrity, and operational excellence for your GMP-regulated life sciences systems — from the Research Triangle to facilities nationwide.
Get Started Today →