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Symbiosis Pharmaceutical Services reduce validation process to just four weeks

Symbiosis Pharmaceutical Services reduce validation process to just four weeks

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.

Benefits

  • 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

Download the Case Study

Q-Pulse is more than a contribution to our quality system - it IS our quality system.

Murray McKay, Quality Director, Symbiosis Pharmaceutical Services 

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