Case Study: Pharmacosmos achieves a fully paperless, unified global Quality Management System with Ennov Quality Suite

Implementing a Total Quality Management Solution to Become Paperless and Unify the Organization

Pharmacosmos, a Denmark-based, family-owned pharmaceutical company, faced fragmented, paper-based GxP and non‑GxP documentation, training records and quality processes (Change Control, Deviations, CAPAs, Complaints, Audits). Seeking a single configurable, 21 CFR Part 11‑compliant system that supported electronic signatures, data integrity and easy validation, Pharmacosmos selected the Ennov Quality Suite—Ennov Doc, Ennov Training and Ennov QMS—to unify and modernize its global quality management.

Ennov implemented a configured, validated eDMS and global training system, delivering Ennov Doc for Quality and Ennov Training with support from an experienced project team. The result was a fully paperless process with electronic signatures, global visibility into SOPs and training status, faster document handling, strong user adoption and successful validation on schedule—demonstrating Ennov’s ability to meet Pharmacosmos’s requirements while reducing manual, paper‑based risk.

Pharmacosmos

Flemming Simonsen

Director