A perfect fit for the validated
Pharmaceutical environment
ERP for the pharmaceutical industry
Pharmaceuticals are becoming increasingly individualized, quality requirements are higher and regulations are numerous: the GUS-OS Suite enables pharmaceutical companies to achieve largely automated and lean production in this environment. Almost 40 years of experience in the pharmaceutical industry have gone into the GUS Group's process-oriented ERP solution. The GUS-OS Suite is currently used by around 60 pharmaceutical manufacturers (human and veterinary medicine), contract manufacturers and pharmaceutical distributors. It ensures the planning, production and delivery of high-quality medicines. All business processes are compliant with regulations. And the industry processes supplied as standard can also be modeled individually for each customer.
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.
ERP for the pharmaceutical industry
These functions are particularly important. Watch the short video now!
ERP validation for pharmaceutical companies
Regulated companies in the pharmaceutical sector that want to introduce new software must check the impact of the system on patient safety, product quality and data integrity. If this is the case, the software must be introduced in such a way that a validated "computerized system" is used at the end of the project. The computerized system is always the complete system, consisting of software, hardware, infrastructure components used and connected devices as well as the specific operation and use within the specific company processes.
If you would like more information, have specific questions or would like to arrange a consultation, please contact us. Our team is here for you!
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:
Validation / GAMP 5
- Laboratory integration according to GLP guidelines for quality assurance, quality control and development as well as test instructions according to AMWHV §14 and §23
- System-supported traceability matrix (Scope Portal) for linking requirement and functional specifications with risk classification according to GxP guidelines
- GMP-compliant supplier qualification and supplier evaluation according to AMWHV § 11 (2)
- GMP-compliant packaging versioning in accordance with GMP Guideline Part I 1.4, 1.9 and 1.10
- GMP-compliant manufacturing documentation in accordance with AMWHV §14 and §23
- GMP-compliant manufacturing instructions in accordance with AMWHV §14 and §23
- Support for the Narcotics Act (BtMG)
- Workflow-supported, multi-stage batch release process with batch register management
- Stability tests according to ICH Q1 A-F, GMP guidelines Part I 6.23-33, reserve sample management according to AMWHV §18 and §27
Data integrity
- Audit Trail Review according to ICH Q10 and Q11
- Compliance with the requirements of MHRA 2015, FDA 2016, PIC 2016
Complete documentation
- all components of a medicinal product or intermediate
- through graphic visualization of batch origin and use
Quality management
- Complaints and returns management incl. recall control
- Audit Manager for the documentation of internal and external audits
- Integrated LIMS for QC/QA according to GLP
- Integrated management of PZN and physician sample dispensing
- Worldwide shipping according to GDP incl. delivery index, batch usability and customer specification comparison
- Calculation of active ingredients and balancing in production according to GMP
- Process control in all modules according to GAMP 5 guidelines
- Traceability and traceability in all process steps in accordance with Annex 11
- Placing the batches on the market incl. batch register according to AMG
- Product Quality Review (PQR)
- Support for price moratoriums and statutory discounts 130a (3a) of the Fifth Book of the German Social Code
Serialization
- for pharmaceutical manufacturers and contract manufacturers
- for pharmacists, wholesalers and clinics
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.
Highlights
- Batch tracing
- Product Quality Review (PQR)
- Hygiene monitoring
- Serialization
- Audit Trail
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 of specific batches can be analyzed, as can the effort required for picking outgoing goods, right through to the capacity utilization figures of 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.
Look & Feel of our ERP software
Curious about the GUS-OS Suite? In our Look & Feel Video you will get a first insight into the heart of our ERP system and gain valuable impressions about an industry-appropriate use.
FAQs
You ask - we answer
ERP stands for Enterprise Resource Planning and can be developed explicitly for the requirements of the pharmaceutical industry. It is a specialized software solution that supports the management of business processes in pharmaceutical companies. It integrates various departments such as purchasing, production, inventory management, sales and finance to improve information flow and increase efficiency.
Typical functions of ERP software for the pharmaceutical industry include support for GAMP 5 validation, batch management, traceability, quality management, document control, recipe management, order processing, inventory management and supply chain management. ERP software may also include financial and human resource management functions.
When implementing ERP in companies from the pharmaceutical industry, challenges such as high costs, complex data migration, training requirements for employees, technical problems and acceptance problems can arise. Thorough planning and professional support, at best from software vendors who have a good understanding of the requirements of companies from the pharmaceutical industry, especially in connection with the necessary validation, can contribute significantly to successfully overcoming these challenges.
GUS ERP GmbH offers a specializedspecialized ERP solution for the pharmaceutical industry. The software enables the integration and management of various business processes in pharmaceutical companies, including batch management, traceability, quality management, document control and much more.
The ERP software GUS-OS Suite ERP software for the pharmaceutical industry offers numerous benefits, such as improved productivity, optimized inventory management, seamless compliance, increased transparency in business processes and improved decision-making. Integrated audit trail, Product Quality Review (PQR), placing batches on the market with batch register according to AMG, support for computer system validation sand a process- rather than document-oriented, workflow-based working method are also among the unique selling points of the GUS-OS Suite explicitly for the pharmaceutical industry.
The ERP software from GUS ERP GmbH is customizable and scalable. It can be adapted to the individual requirements and business processes of pharmaceutical companies and grows with the company to adapt to future requirements.
Modern ERP systems for the pharmaceutical industry, such as the GUS-OS Suite, are flexible and can be integrated with other systems, such as customer relationship management (CRM) and supplier portals, and easily linked via interfaces.
Further industry solutions
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