Lek is member of the Sandoz group, the generic division of Novartis, a pioneer in the field of biosimilar biological medicines and second largest manufacturer of generic medicines in the world. Lek manufactures pharmaceutical and biotech active substances, pharmaceutical products and biological medicines
Data integrity including an implementation a reference central data repository represents the basis for compliance with good manufacturing practice and producing products of highest quality of products. Therefore Lek, in particular its solids, sterile and biotech production departments took the decision to implement the MePIS PDM and PDM solutions.
The MePIS CDE
and MePIS PDM
solutions provide Lek with a validated central storage for contextualized production data and the possibility of its in-depth analysis. The central data repository represents a reference source of continuous and reporting data for all further processing. It stores also alarms and audit-trail data as well as all production reports, which are at any moment of time accessible via a web-application. Apart from the basic data display the analytical part of MePIS PDM features also comparison of batches, comparison of measurements with alarms on the same screen and analysis of the most frequent alarms on a certain equipment or the site as a whole.
Lek has improved data integrity and the associated regulatory compliance of the manufacturing process and at the same time gain a better insights into production process.