Case Study: Ortho Molecular Products achieves affordable, reliable critical document management and regulatory compliance with DocXellent's ENSUR

Out of the Box, ENSUR Helps Ortho Molecular Products Manage Critical Documents Affordably, Reliably

Ortho Molecular Products, a nutritional supplements company, needed a validated electronic document management system to meet FDA (21CFR) requirements and replace an unvalidated, hard‑copy reliant SharePoint setup that made approvals, version control, and retrieval difficult. After evaluating options, the company selected DocXellent’s ENSUR as a commercial off‑the‑shelf DMS that could be deployed without costly custom development.

DocXellent implemented ENSUR with a 10‑step validation process, administrator training, and user onboarding, then rolled out additional CAPA and training modules. The ENSUR deployment eliminated the hybrid SharePoint process, improved compliance and content integrity, reduced staffing (eliminating one FTE), avoided an estimated $250k–$300k and four years of custom development, and—with new incident/CAPA tracking—saved manufacturing supervisors about five hours per week in one department.

Ortho Molecular Products

Albert Webster

Computer Software Validation Coordinator