Case Study: VirtualScopics achieves enhanced product development visibility and FDA compliance with Perforce Helix ALM

VirtualScopics & Helix ALM for Enhanced Product Development Visibility

VirtualScopics, a medical imaging core lab serving pharmaceutical and medical device clinical trials, needed better visibility across its product development lifecycle and stronger support for FDA compliance, especially 21 CFR Part 11. The company was struggling with disconnected issue and project management tools, difficult reporting, and limited traceability as its many concurrent projects grew in complexity. Perforce’s Helix ALM was selected to help manage requirements, defects, features, and test cases in one system.

Perforce implemented Helix ALM and its Requirements Management module, giving VirtualScopics electronic signatures, audit trails, traceability, and easier management reporting. The solution improved compliance readiness, made project status and priorities easier to track, and allowed a 150-page requirements document to be imported in about 30 minutes. VirtualScopics reported the rollout was smooth and described Perforce’s product as one of its best software investments.

VirtualScopics

Colin Rhodes

Director of Software Development