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 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 validation testing of complex systems across the manufacturing lifecycle — from Level 0 through Level 4, including ERP, MES, DCS, physical equipment/sensors/actuators, LIMS, and QMS as defined in ISA-95. 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 (ISA-95)
Enterprise Resource Planning (ERP) — Level 4
Validation of business planning and logistics systems that establish plant production scheduling, material use, delivery, and shipping, as well as resource management, financials, and supply chain operations as defined in ISA-95.
Manufacturing Execution Systems (MES) — Level 3
Validation of manufacturing operations management systems that manage production workflows, dispatching, detailed scheduling, electronic batch records, and real-time performance analysis as defined in ISA-95.
Batch, Continuous & Discrete Control (DCS/PLC) — Level 2
Validation of control systems responsible for monitoring, supervisory control, and automated control of the production process, including batch control per ISA-88 (S-88) and continuous/discrete control per ISA-95.
Sensors, Actuators & Equipment — Levels 0–1
Validation of physical process equipment, sensors, transmitters, actuators, and safety instrumented systems that define the actual production process and provide sensing and manipulation of the manufacturing environment.
Laboratory Information Management Systems (LIMS)
Validation of laboratory systems managing sample tracking, analytical testing, data management, and quality control laboratory workflows, supporting ISA-95 Level 3 quality operations management.
Quality Management Systems (QMS)
Validation of quality management platforms managing deviations, CAPAs, change control, document control, and quality event investigation, supporting ISA-95 Level 3 quality operations management.
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.
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