Symbiosis Pharmaceutical Services, a leading small-scale contract manufacturer of novel injectable pharmaceuticals for use in clinical trials, has drastically reduced the validation process for their electronic quality management system (QMS) - with help from Ideagen.
The company required to have their electronic QMS validated to comply with FDA requirements - which can be a lengthy process taking up to six months. To speed up this process and to have support through this complex and lengthy task, Symbiosis used Ideagen’s validation documentation templates.
As a result, Symbiosis was able to validate their system in 4-6 weeks, as opposed to 4-6 months.
- Ideagen’s validation service helped Symbiosis validate their system in 4-6 weeks as opposed to 4-6 months
- Set templates provided by Ideagen offered support to Symbiosis’ validation efforts, including support with core IT system requirements and properties
- Bespoke Validation Plan developed, helping Symbiosis achieve compliance with key regulatory requirements
Q-Pulse is more than a contribution to our quality system - it IS our quality system.Murray McKay, Quality Director, Symbiosis Pharmaceutical Services