GUS-OS Suite
ERP system with vision
Quality management
The GUS-OS Suite ensures that all quality- and value-related data is tracked throughout the entire lifecycle of a batch - from the creation of item master data, through the preparation, receipt, reservation, and disposition of a raw material, bulk, or end product, to its sale or marketing. Consistent batch origin and usage records ensure that every batch purchased or produced can be traced back in detail, even in subsequent products, and recalled if necessary.
Quality control
GUS-OS Quality Control controls the testing, processing and monitoring of batch stocks. The module supports the monitoring of release dates, retest dates, expiration dates, and remaining lead times. In addition to incoming goods inspection, in-process control and the issuing of corresponding quality certificates at batch level (raw, bulk or finished goods), workflow-supported processes for batch blocking (including recall), for example, are stored in the GUS-OS Suite.
Stability control
All stability tests can be performed with the GUS-OS Suite at different climatic conditions at several firmly defined test times. A stability specification is composed of several specifications as used for release. Such a specification with several specification items is defined for the individual test times and climatic zones.
Audit Trail
Based on regulatory requirements, GUS-OS Audit Trail monitors and logs all data and data changes made in the GUS-OS Suite over a defined period of time. In addition to the documentation of master data in the GUS-OS Suite, both transaction data and metadata are included. There is complete documentation of all changes to GMP-relevant data as well as documentation of direct database changes outside the GUS-OS application. This ensures a high level of data integrity.
Audit Manager
Product development
The GUS-OS product development actively supports you in the development of new products as well as in the modification of formulations. Functionally, the comfortable and simplified creation of development materials and simplified maintenance of development recipes is provided. The administration of different recipe states by corresponding version management is included as well as the development calculation of the recipes/bill of materials.
Integrated laboratory
The GUS laboratory information management system covers laboratory functions such as incoming goods inspections, in-process controls and final controls for finished goods. In addition, studies on shelf lives of pharmaceutical products are handled by the GUS-OS Stability Testing module. As part of the quality assurance system, the Product Quality Review (PQR) fulfills regulatory requirements. In addition to functions such as certificate generation and specification comparison, extended test equipment monitoring is also part of the solution. Integration into product development is provided, as is the creation of deviations (OOS) and measures (CAPA). Quality control is batch and process oriented.
Serialization Hub
Prescription drugs may now only be marketed in Germany if they bear an individual serial number on their packaging. To meet the requirements for pharmaceutical companies resulting from these regulations, a corresponding feature bit was developed in cooperation with a partner company. This enables you to fully meet the serialization requirement.
securPharm
The feature bit "securPharm connection pharmacy server" enables wholesalers to authenticate themselves directly on the pharmacy server via the GUS-OS Suite. In this way, incoming drugs can be verified quickly and easily, and dispensed or destroyed drug packages can be reported out.
Product Data Management
The GUS-OS product data management module supports companies in the food industry as well as cosmetics manufacturers in compiling or calculating information for the declaration of their products. The module offers the building blocks maintenance of nutrients, allergens, ingredients, INCI data on the level of the purchased parts and enables the fulfillment of food law regulations as well as cosmetic regulations.
Weighing
Supplier evaluation
With the supplier evaluation in GUS-OS, evaluation criteria can be defined for the areas supplier, goods receipt, laboratory and invoice receipt. In addition, it is possible to record decentralized evaluations as well as to carry out a cyclical evaluation of suppliers and also automatic evaluation of adherence to delivery dates and quantity deviations. The release of sources of supply is workflow-controlled, so that processes are meticulously executed and at the same time it is ensured that orders can only be placed with verified suppliers.
UDI master data management
Every medical device in the EU must be given a unique device identifier (UDI) in accordance with the European Medical Devices Regulation.
A UDI consists of two parts:
- The UDI Device Identifier (UDI-DI) identifies the medical device.
- The UDI Production Identifier (UDI-PI) identifies production units of the product and can contain e.g. serial number, lot number, software identification, date of manufacture or expiry date
The basic UDI-DI is the primary identifier of a product model (like a product group). For this purpose, the GUS-OS UDI module provides appropriate management programs for mapping the base UDI-DI and UDI-DI.
Complaint Management
Certificate management
The Bit GUS-OS certificate management feature offers the possibility to store, release and monitor both certifications of business partners (e.g. supplier certifications) and own certifications requested by business partners (e.g. customers) in the system.
Mastering challenges in the process industry
Short development cycles, multi-stage manufacturing processes, restrictive legal requirements, strict certification requirements, and high demands on quality and environmental management: This poses major challenges for companies in the process industry and their IT systems
- especially since legal and industry-specific requirements and regulations differ from country to country and change frequently. With the GUS-OS Suite, we provide a modular solution with which companies can control complex processes across the entire value network in a consistent, integrated and yet flexible manner thanks to fully integrated workflow management. Find out how this works in our module information.
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Feature Pack 7.0 of the GUS-OS Suite
With Feature Pack 7.0, the latest version of the GUS-OS Suite is now available. Besides additional modules, it offers a multitude of new functions. Highlights of the Feature Pack are the comprehensively modernized user interface and the optimized update procedure. The GUS-OS Digital Hub Service has also been further expanded. The cloud-based service now offers extended display options as well as new, ready-made solution modules to improve communication with the field service.
Entry into digitization
The GUS-OS Digital Hub Service is a cloud-based service that allows you to individually make the processes of your GUS-OS Suite accessible outside your company. Business partners and external employees can interact directly with your ERP system, retrieve, set and update data via the web app. Get to know our Digital Hub now!
