Stability studies include complex processes to test how long a product can maintain its original quality specifications under normal use conditions, as well as the study of product-related factors that influence the quality, such as the interaction of the active pharmaceutical ingredient (API) with excipients, container-closure systems, and packaging materials.
The burden of proof is on the manufacturer to prove all claims are accurate, which includes proving the validity of data and producing documentation in real-time to satisfy auditors.
With Labwise XD, labs can manage stability studies digitally, reducing mistakes that occur with manual paper-based processes. The Labwise XD stability module features quality, compliance, and electronic lab notebook (ELN) functionality that creates a comprehensive solution for assuring compliance with regulatory guidelines globally.
