Case Study: IronShore Pharmaceuticals achieves rapid, FDA‑ready eQMS implementation to prepare for commercialization with ZenQMS

IronShore Pharmaceuticals Chooses ZenQMS to Prepare for Commercialization

IronShore Pharmaceuticals, the US commercial arm of IronShore Pharmaceuticals & Development, faced an urgent need to replace a largely paper‑based, non‑21 CFR Part 11 compliant quality system and wet‑ink signatures before launching their first commercial product, DELEXIS. Tasked with selecting both an eQMS and LMS to meet FDA and commercialization requirements, IronShore chose ZenQMS for its integrated, validated solution and user‑friendly interface.

ZenQMS implemented an integrated eQMS and training/tracking solution with components for CAPAs, Deviations, Complaints, and Change Control; validation and deployment took less than a month and included department‑specific onboarding and a dedicated ZenQMS project manager. The rapid, low‑resource implementation and trouble‑free validation enabled fast commercialization readiness, ongoing use on IronShore’s commercial side, and plans to extend ZenQMS to R&D.

IronShore Pharmaceuticals

Ritesh Mehra

Manager of Quality Systems