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.
Labwise XD handles all types of statistical models ensuring an accurate shelf-life evaluation, including:
Includes product, batch, and storage conditions.
Includes desired storage conditions and time intervals.
Specify a start time for each storage condition.
Print labels and store samples.
Enter results on Lab Work Order (LWR) forms.
Pull lab work order, activate the study, verify & approve the results.
Run calendar and request sample pulls.
View last approved LWR.
Analyze and write stability reports.
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.
ECM XD enables collaboration with all stakeholders and derives insights and intelligence from digital documents and metadata.
CQRM XD is a low-code software that helps businesses operating in regulated industries manage compliance, risk, and quality.
ECM XD enables collaboration with all stakeholders and derives insights and intelligence from digital documents and metaaCorrective and Preventive Action (CAPA) can be a daunting task for quality-minded organizations.data.
Predictive Compliance to be always ready for any compliance requirements.
105 College Road East
Princeton, New Jersey 08540
105 College Road East
Princeton, New Jersey 08540
105 College Road East
Princeton, New Jersey 08540
105 College Road East
Princeton, New Jersey 08540