Industries

CSV for Diagnostics Companies, What Is Different

How computer system validation obligations differ for diagnostics companies compared to traditional drug manufacturers.

CSV for Precision Medicine and Genomics Labs

What makes computer system validation different for precision medicine and genomics labs, where pipelines and reference data both matter.

Validation Obligations for CLIA Labs

What CLIA certification means for computer system validation, and how it overlaps with and differs from broader GxP expectations.

Validation Obligations for CAP Accredited Labs

How College of American Pathologists accreditation checklists intersect with computer system validation for laboratory systems.

Validation for Cloud Hosted Lab Information Systems

What changes about validation when a lab information management system moves to a cloud hosted, vendor managed platform.

Validation for Electronic Quality Management Systems

What validating an eQMS actually involves, and why configuration is usually where the real risk sits.

What a Growing Biotech Gets Wrong About CSV

Common computer system validation mistakes a growing biotech company makes as it scales past its first few regulated systems.