Validation of GxP systems is required to assure they are fit for intended use and compliant with applicable regulations. However, the same rigor is often applied to all system changes – regardless of potential impact.
Written by members of the community, led by Sean Smith from Blueprint Medicines, this position paper proposes a risk-based approach to streamlining GxP system configuration changes and release updates – without compromising the quality of the “system product” or the integrity of the validated state. Adopting a risk-based approach to configuration change management enables companies to efficiently keep systems up-to-date, leverage new functionality, and continuously meet business and end-user requirements.
Please Note: the position will be widely available in November.
Please register below to be the first to receive a copy.