There is no alternative to validation for pharmaceutical businesses — this standard is required by law. However, there are alternatives in how these standards are fulfilled. Even the GAMP Guideline proposes more efficiency: “When possible, health care companies should streamline their validation planning by integrating the supplier’s specifications, tests and quality documentation.“
The Bombastus-Werke AG, the largest certified, in accordance with ecological EU guidelines, producer and processor of perennial sage in Europe, thus pays special attention to lean prospective validation. Another principle of theirs is to also follow — in accordance with their business philosophy — a holistic approach in software innovation. For the new solution, this means that all important business processes, and obviously also business standards, must be incorporated.
Thus, the company is now investing in the integrated business solution GUS-OS ERP. Consequently, a stable and secure foundation for company growth is assured. The system is set up to further enhance the transparency and quality orientation of the Bombastus business processes and offers the necessary control possibilities. The solution uses one IBM xServer as the database server and one as the application server. For the database, the GUS Group installed the SQL Server 2005 from Microsoft for the pharmaceutical company.
With the integrated software, the company can consolidate their business processes. The application integrated workflow takes care of handling the entire value-added and quality processes. In addition, revalidation as well as future software releases can be realised with GUS-OS ERP, which saves resources.
Along with the ERP-solution, seven additional modules from the GUS-OS solution family were implemented. Among others, these are functions for documentation of the process history as well as CRM-components, planning and reporting modules and also a laboratory information management system.
“With GUS-OS ERP, we are providing our employees with a system that always provides up-to-date information about current projects. This reduces mistakes and creates more efficiency.”
Siegfried Anke, Director, Bombastus-Werke AG
