Computer Systems Validation (CSV)

Why Us

When working with ViridianTechs, you can expect a seamless, FDA and EMA compliant, customized solution to all your computer systems validation needs. With our consulting experience in the life science industry, we fully understand that computer systems are vital for a company’s success. Our specific areas of expertise within computer systems validation are included below. Developing and bringing life-changing drugs and devices to market: that’s your job. Expert computer systems validation consulting: that’s ours. You have enough to accomplish; let us be your resource for computer systems validation. As a global leader specializing in computer systems validation consulting services, ViridianTechs work to ensure life sciences companies’ processes are functional and fully compliant with FDA and EMA guidelines.

Data Integrity

• Attributable, Legible, Contemporaneous, Original, Accurate (ALCOA) + Complete, Consistent, Enduring, Available
• Audit-trail reviews and electronic signature testing
• Access-control checks and user-role verification
• Risk-based CFR Part 11 compliance assessments
• Gap analysis, remediation planning, and training programs

CSV Specialties

ViridianTechs brings deep expertise across a wide array of computerized systems: Laboratory Information Management Systems (LIMS) and Electronic Lab Notebooks (ELN), MES and ERP integrations for batch traceability and recipe management, SCADA & HMI platforms for real‐time monitoring and alarm handling, time-series Data Historians for trending and reporting, and qualification of analytical instruments including chromatography, spectroscopy, and mass spectrometry.

Our consultants craft a risk-based validation strategy for each system, complete with clear traceability matrices, robust test scripts, and audit-ready documentation—so you can focus on your core research and production goals.

Plant Maintenance & Asset Management System Implementation & Validation

We implement and validate CMMS/EAM solutions that keep your equipment running at peak performance. From work‐order automation and preventive maintenance scheduling to spare‐parts inventory controls and calibration tracking, our approach ties operational data into comprehensive compliance dashboards.

Leveraging our knowledge of regulatory mandates, we guide you through system configuration, data migration, database validation, user training, and change‐control processes to deliver a turnkey asset management platform that’s audit-ready from Day 1.