As part of the pharmaceutical and biopharmaceutical development and chemistry, manufacturing and controls (CMC) activities, reports need to be regularly generated and distributed. If any change or additional evaluations must be made after a report has been created, the data scientists need to make sure that the original data base is used for the revision of the report. Additionally, they need to provide evidence for equality between data analysis results, even if they have been generated at different points of time and by different users.
“With Werum PAS-X Savvy, it is possible to keep track of changes between report versions in an automated and user-friendly way,” says Dr. Daniel Borchert, Product Manager Software, Körber Business Area Pharma. “Our data science platform analyzes the results of different reports and their underlying elements, such as plots, variables, calculations and identifies the type and position of differences.“
The entire data hierarchy will be verified, including import, derived data, templates for calculations, plots and tables as well as the reports themselves. In case any discrepancy is detected, PAS-X Savvy will show on which hierarchical level the change has occurred and when and by whom it has been made.
“Our customers in the pharmaceutical and biopharmaceutical development industry benefit from the certainty of knowing that the same data and scientific methods are used in their reports. With the new PAS-X Savvy functionality ‘Trace’, data scientists can ensure data integrity, even in a non-GMP environment, and thus help accelerate the time-to-market of new products,” says Dr. Daniel Borchert, Product Manager.
