Change Control through QMS Xpress offers a standardized process for workflow flexibility, allowing a life sciences manufacturer to manage all types of changes from one centralized platform. The ability to manage and control changes is critical for the life science industry to maintain organizational quality, meet business challenges, GxP compliance, and regulatory obligations.
Change control monitors all types of changes. These changes can influence the reliability or product quality, impact relevant requirements, and determine what’s necessary for implementing or not implementing the change.
Following GMP/ISO standards and requirements, all changes must be documented to prove that the change was evaluated (risk analysis) and the subsequently defined measures were implemented as predetermined. With a cloud-based QMS, companies have better data control and drive data quality significantly, allowing for collaboration across all departments.
A cloud based software solution allows anyone that provides input, reviews, manages or is responsible for changes for any quality events to access the quality events, anytime and where.
You can drive quality through pre-defined templates and controlled configurations with the flexibility to adapt to your changing organizational needs.
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