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.
With Labwise XD – Stability Management, you can:
Labwise XD handles all types of statistical models ensuring an accurate shelf-life evaluation, including:
Most traditional stability systems either free-standing or part of other LIMS and ELN require additional IT systems or significant manual processes to ensure other important business aspects such as documentation, deviation management, CAPA, audits, and people competency. Xybion Lab Management Solution is one stop platform-based solution to provide the core and additional required solutions.
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.