Reliable in a Validated  

  Pharmaceutical Environment  

ERP for the Pharmaceutical Industry

The GUS-OS Suite creates the functional framework conditions in an environment subject to validation that are necessary for the reliable planning, production and placing on the market of high-quality pharmaceuticals. We advise pharmaceutical companies in the development of IT-supported process improvements and provide answers to current and future regulatory and business management questions. Our aim is to further optimize the efficiency and transparency of business processes.

Standard Version Takes Process Requirements of the Pharmaceutical Industry into Account

Our application-integrated process control (workflow engine) handles all agreed business processes reliably and, in accordance with regulatory guidelines such as GAMP 5, GxP or compliance requirements, does so safely. The standard version of the GUS-OS Suite covers a wide range of pharmaceutical-specific requirements, such as

  • multi-stage product development,
  • convenient formula administration,
  • batch analyses at all stages,
  • batch-oriented proofs of origin and usage,
  • audit trail to document system changes,
  • electronic signature according to the 2 and 4-eyes principle,
  • Product Quality Review (PQR),
  • simulations for planning decisions.

The GUS-OS Suite Proves Flexibility

Frank Heim
Finzelberg GmbH

As one of the world’s leading manufacturers of phytopharmaceutical extracts, Finzelberg offers dietary supplements as well as comprehensive services for pharmaceutical products from their development to their registration. They have optimized their processes with the GUS-OS Suite and are very satisfied with the quick adaptability to special requirements, among other things.

Highlights

  • Batch tracking
  • Product Quality Review (PQR)
  • Hygiene monitoring
  • Serialization
  • Audit trail

More References

GUS solutions in use: Take a look at the references from the pharmaceutical sector!

Process Improvement in Real Time

The business intelligence solution (BI) integrated in the GUS-OS Suite calculates process and financial figures in real time. These key performance indicators (KPI) establish the necessary process transparency, thus providing fact-based decision-making aids to adapt and optimize processes at short notice. In addition to daily evaluations on an hourly basis, forecasts and projections into the future are also possible. This makes it possible to analyze lead times of specific batches, as well as the time and effort required for order picking, and the capacity utilization figures for individual production areas.

Process Development in Product Serialization

Our pharmaceutical consultants work together with the companies to develop the business processes necessary for implementing the EU Counterfeiting 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 unique coding of the secondary packaging of pharmaceuticals to protect against plagiarism.

Other branch solutions:

Getting in Touch

Did we spark your interest? Do you have any further questions? Would you like further information? We look forward to talking to you!