EASIER CREATION OF PQ & APRS.
Both the FDA (Food and Drug Administration) and the EMA (European Medicines Agency) demand annual, product-related reports of all manufacturers of pharmaceutical products. The preparation of these reports (Product Quality Reviews (PQR), Annual Product Reviews (APR)) is very time consuming and requires a great deal of manual effort.
LiSI ValidReports (LiSI = Life Sciences Intelligence) allows customers of the regulated industries to automatically generate necessary regulatory documents like PQR, APR or complete batch reports, and to release them validated.
This provides an efficient solution for the requirements of the FDA and EMA requesting annual product-related reports by all manufacturers of pharmaceutical products. LiSI ValidReports generates reports with the push of a button without the need for time-consuming data compilation. All reports based on released templates can be tested and approved through flexible workflows. The complete system works paper-free, without time-consuming manual research.
LiSI ValidReports simplifies the connection to databases and OPC servers significantly without requiring extensive IT expertise. In daily business with data and process values, it often happens that relevant data is stored in disparate systems that do not communicate directly with each other. Data that must be included in documents relevant to the authorities is stored in different databases, tables or files. Thus LiSI ValidReports offers a wide range of possibilities.
- Validated templates and reports meet the highest requirements
- Automatic creation of APRs and PQRs
- Complete batch releases - paperless, supported by workflows
- Easy handling without IT dependency
- Trendsetting through the use of the latest technologies
|Reduction of manual collection of data||Automated access to all available databases|
|Avoidance of data redundancies||Real-time virtual data access – without limiting the performance of the source systems|
|Electronic release of necessary regulatory reports||Version- and workflow- support in a paperless system|
|Paperless batch release||Batch documentation is possible at the push of a button, in one system|