Validation as a Service Model

PROJECT OVERVIEW

CAI implemented a Validation as a Service model for companies in early-phase clinical trials, addressing the need for speed to patient without requiring a large internal validation department. By leveraging Kneat’s eVLMS platform, CAI established an in-house program with standardized procedures and off-the-shelf content deployable on a project-by-project basis. This approach allowed for rapid project initiation, reduced document development times, and in some cases, eliminated the need for pre-execution review. The model was successfully applied to a small CDMO, resulting in significant cost savings, accelerated timelines, and early identification of equipment issues.

Topics Covered

• Standardized validation procedures for clinical trial companies
• eVLMS platform implementation for streamlined processes
• Pre-approved templates for common validation tasks
• Cost reduction in validation projects
• Accelerated project timelines in pharmaceutical validation
• Early issue identification and resolution in equipment qualification
• Compliance with data integrity and electronic signature regulations