Case Study: Symbiosis Pharmaceutical Services achieves four-week QMS validation with Ideagen's Q-Pulse

Ideagen helps pharmaceutical company reduce their validation process to four weeks

Symbiosis Pharmaceutical Services, a contract manufacturer of novel injectable pharmaceuticals for clinical trials, needed to validate its electronic quality management system to meet MHRA, GMP and FDA requirements — a process that can typically take four to six months. Facing an upcoming regulatory audit, the company required a fast, compliant validation without diverting excessive time and resources.

Working with Ideagen and its Q-Pulse validation service, Symbiosis used supplied templates (URS, DDS, CSVP, CSVR), configuration checklists and a Certificate of Conformance to streamline documentation and testing. The templated approach cut the validation timeline to about four to six weeks, saved significant time and resources, and enabled a bespoke Validation Plan that achieved regulatory compliance.

Symbiosis

Murray McKay

Quality Director