iStudyReporter Stability SAPQM

Strategy
The strategic business goal of many companies in the Life Sciences is to combine research and development with general business strategies. You will need seamless integration of the various laboratory areas in the supply chain to make the most efficient use of your business processes, a current trend in the regulated market supported by SAP for Life Sciences.

Stability
Stability studies play an especially crucial role in pharmaceutical drug and product development and approval. SAPQM  implements stability processes from planning to performing in accordance with regulatory directives.
However, streamlining current laboratory processes from data acquisition to fully automated approval report generation while taking specific national regulations into account is absolutely decisive in complete research data management optimisation.

Solution
Our iStudyReporter package gives you a scalable, versatile reporting solution to minimise the complexity involved in preparing regulatory reports since the reporting process is completely automated, supporting a whole variety of report formats from Certificate of Analysis and MS Word formats to shelf-life reports to full PQR/APR out of the box.

Benefits at a glance

• Improved process quality by streamlining laboratory processes
• Continuous process improvement from data collection to final approval
• Risk minimisation by eliminating potential sources of error inherent to manual regulatory report preparation
• Increased product quality
• Reduced costs and increased speed in reporting processes
• Options for interfacing to any external database system