|Leverage your Stability LIMS in QC and CMC departments by using an established solution to generate your complete stability reports for submission. No more tedious LIMS implementation projects with customized individual reports for regulatory approval. By making use of StudyReporter Stability you get a solution that integrates seamlessly with your LIMS and generates Stability Reports in the shortest time based on regulatory requirements.
StudyReporter Stability comes with a set of predefined and customizable interfaces to all common LIM-systems such as SampleManager LIMS™, LabWare LIMS or LabVantage or Lab notebooks. Data from several systems can also be merged, e.g. from a legacy system and a current system.
Pre-qualified table representations can be used in custom Word templates. Templates can be configured for a wide variety of purposes – whether initial approval, Ongoing Stability or PQR and APR. During generation, relevant issues such as unknown impurities, spelling errors in parameter frames, changed method definitions or the use of country-specific product specifications can be addressed and mapped easily.
Sophisticated statistical analyses that can otherwise only be implemented in separate packages with loss of data integrity are already included in StudyReporter Stability. This eliminates the need for external programs, service providers and the time-consuming revalidation of reports.