Safe in a Validated Environment
ERP for Pharmaceuticals
In an environment in which validation is mandatory the GUS-OS Suite establishes the functional framework conditions required for safe planning, production, and placement of high quality drugs on the market. At the same time we advise drug manufacturers on developing IT-supported process improvements and provide answers on current and future regulatory and business matters. Our aim is to further optimize the efficiency and transparency of business processes.
Standard Version Takes Drug Industry Process Requirements into Account
Our application-integrated process control (workflow engine) handles all agreed business processes reliably and, in keeping with regulatory provisions like GAMP 5, GxP and compliance provisions, does so safely. The GUS-OS Suite covers in its standard version a wide range of pharmaceuticals-specific requirements, such as
- Multi-stage development of products
- Comfortable formula administration
- Batch-oriented proofs of origin and utilization
- An audit trail to document system changes
- An electronic signature based on the 2- and 4-eyes principle
- A product quality review (PQR)+
- Simulation for planning decisions
Process Improvement in Real Time
The business intelligence (BI) solution built into the GUS-OS Suite calculates process and financials in real time. These key performance indicators (KPIs) establish the necessary process transparency and thereby provide fact-based decision-making aids to adapting and optimizing processes at short notice.
In addition to daily evaluations on an hourly basis, forecasts and projections into the future are possible. Lead times for specific batches can be analyzed, as can the cost of picking outgoing goods and the capacity utilization rates for individual production areas.
Process Development in Product Serialization
Our pharmaceuticals consultants develop together with the customer the business processes that are required to implement the EU’s Falsified Medicines Directive 2011/62/EU. They then expand the standard processes mapped in the GUS-OS Suite by adding company-specific processes. The outcome is clear: a clear-cut coding of secondary drugs packaging to provide protection from product piracy.
- Batch tracking
- Product quality review (PQR)
- Hygiene monitoring
- Audit trail
Cooperation from the Very Beginning
Continuously engage in dialogue, express expectations and goals, exchange knowledge and expertise, listen and think actively. Thanks to our comprehensive expertise in industry and process-related issues we are able to out forward real and concrete solutions for an effective and flexible workflow management during the implementation project.
Efficiency and flexibility are company properties to gain a competitive edge. Exploit existing potential. Become faster and better. At this we assist you after Go-Life with a variety of services.