LiSI ValidReports - Easy Generation Of Regulatory Documents
Both the FDA and the EMA 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 high manual effort.
LiSI ValidReports (LiSI = Life Sciences Intelligence) allows customers of the regulated industries to generate necessary regulatory documents like Product Quality Reviews (PQR) or Annual Product Reviews (APR) or even complete batch reports automatically and to release them validated.
Thus, it 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 click of a button without time-consuming data compilation. All reports based on released templates can be tested and approved through flexible workflows. The complete system works paperless – without time-consuming manual inquiries.
LiSI ValidReports – Our services
Lisi ValidReports simplifies connection to databases and OPC servers significantly without requiring time-consuming 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 authority’s relevant documents are located in different databases, tables or files. Thus LiSI ValidReports offers a wide range of possibilities.
- Validated templates and reports meet your requirements
- Complete batch releases – paperless, supported by workflows
- Easy handling without IT dependancy
- <trendsetting by using the latest technologies
LiSI ValidReports – Your benefits
|Reduction of manual collection of data||Automated access to all available databases|
|Avoidance of data redundancy||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 releases||Completed batch release possible – one click, all-in-one system|