A perfect fit for the validated  

 Pharmaceutical environment  

ERP for the pharmaceutical industry

Pharmaceuticals are becoming more and more individualized, quality requirements are higher and regulations are numerous: The GUS-OS Suite enables pharmaceutical companies in this environment to achieve largely automated and lean production. Almost 40 years of experience in the pharmaceutical industry have gone into the GUS Group's process-oriented ERP solution. Currently, the GUS-OS Suite is used by around 60 pharmaceutical manufacturers, distributors and contract manufacturers. It ensures planning, production and delivery of high-quality pharmaceuticals. All business processes are compliant with regulations. And the industry processes included in the standard can be modeled for individual customers at the same time.

Because of their dynamic market environment, pharmaceutical companies have to adapt their processes and software again and again. For this purpose, they need, for example, improved calculation schemes for external product and service offers, IT applications for tender management or tools for supplier evaluation. The GUS-OS Suite is specially designed for the process industry and offers corresponding functions. In addition, GUS Group consultants work with customers to find answers to other regulatory and business management questions. Always with the goal of optimizing the efficiency and transparency of business processes.

Product brochure

GUSOS Pharma image - GUS-OS Suite - GUS ERP

What the pharmaceutical industry needs

Even in its standard version, the GUS-OS Suite covers a large part of pharma-specific requirements - and takes into account all important regulations such as GAMP 5, GxP or the Serialization Directive 2011/62/EU. The standard functions of the GUS-OS Suite include:

  • Consistent validation-compliant process control in accordance with GMP, among other things, and support for computer system validation
  • Audit trail ensures data integrity, traceability and retraceability in all process steps
  • Business Intelligence (BI) calculates process and financial key figures in real time. On this basis, processes can be optimized quickly and accurately and capacity utilization can be increased.
  • Digital Hub Service for data exchange and communication with external partners
  • Complete documentation of batch origin and use
  • For quality assurance and development: Laboratory integration according to GLP guidelines as well as test instructions according to AMWHV §14 and §23
  • Traceability matrix (Scope Portal) links requirements specification/ specification with risk classification according to GxP guidelines
  • Stability tests according to ICH Q1 A-F, GMP Guideline Part I 6.23-33, reserve sample management according to AMWHV §18 and §27
  • Worldwide shipping according to GDP guidelines
  • Support for price moratoriums and statutory discounts
  • Integrated serialization process

The GUS-OS Suite in practice

Frank Heim
Finzelberg GmbH

Finzelberg is one of the world's leading manufacturers of phytopharmaceutical extracts, offering nutritional supplements as well as comprehensive services for pharmaceutical products from their development to their approval. With GUS-OS Suite, they have optimized their processes and are very satisfied with the fast adaptability to special requirements, among other things.


  • Batch tracing
  • Product Quality Review (PQR)
  • Hygiene monitoring
  • Serialization
  • Audit Trail

More references

The GUS solution in use: See more pharma references. 

AdobeStock 391453400 Editorial Use Only - GUS-OS Suite - GUS ERP


GUS-OS has already been in use at BioNTech since 2017 at the main site in Mainz in the area of mRNA-based, individualized cancer vaccine candidates. In the course of setting up production for clinical trials there, GUS-OS was introduced to map the internal logistics processes. The range of tasks covered by the GUS-OS suite extends from requirements planning and provision of components for patient-specific production to the shipment of cancer vaccine candidates to participating hospitals, for example, as part of the ongoing study.

Fig4 Bombastus sage harvest - GUS-OS Suite - GUS ERP


The ERP system as control center At the natural remedies producer Bombastus, the ERP solution GUS-OS Suite is increasingly taking on the role of control and data center. The system ensures that the right data is available in the right place. Bombastus has, among other things, connected its web store on this ERP basis. The opportunity At Bombastus, the end customers have recently moved even further into focus.

AWB Magnesia - GUS-OS Suite - GUS ERP


Magnesia plans with the GUS-OS Suite MAGNESIA GmbH has been a global supplier of high-quality magnesium, calcium, zinc and other mineral compounds for 40 years. The Lüneburg-based company supplies these raw materials to customers in the pharmaceutical, cosmetics, food, food supplement and chemical-technical industries. In the future, MAGNESIA will organize the complex and regulated business processes around these industries with, among others


Process improvement in real time

The Business Intelligence (BI) solution integrated in the GUS-OS Suite calculates process and financial key figures in real time. These key performance indicators (KPI) create the necessary process transparency and thus offer 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 possible. In this way, throughput times for specific batches can be analyzed, as can the effort required for picking outgoing goods, right through to the capacity utilization figures for individual production areas.

Process development for the serialization of products

Together with the companies, our pharmaceutical consultants develop the business processes required for the implementation of the EU Falsification Directive 2011/62/EU. They then extend the standard processes mapped in the GUS-OS Suite to include company-specific processes. The result is clear: clear coding of secondary pharmaceutical packaging to protect against plagiarism.

Other industry solutions:

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