Life Sciences / Pharma

Process competence Life Sciences / Pharma

ORSOFT has been working for companies in the pharmaceutical industry since the company was founded in 1990. ORSOFT consultants speak your language and know the requirements of all production stages in the pharmaceutical industry.

ORSOFT's software can map various specifics of the industry:

  • Strategical planning for periods of up to 10-15 years is an essential factor in order to be able to build up capacities in advance for strategic products that are still in research.
  • Inventory planning and optimization across different plants, often across several countries and many production stages, must ensure that high product availability (OTIF>95%) is guaranteed.
  • Contract manufacturers often play a crucial role and must be integrated into the planning process.
  • QC laboratories play an important role in pharmaceutical production and are often a capacitive bottleneck in the supply chain. The actual tests for production and raw materials not only have to be completed on time in sync with production, they often collide with capacity requirements from stability studies and clean room testing, or changing quality situations lead to additional work and thus delays. Lack of documentation or QA/QC approvals may also have an impact on schedule production.
  • The issue of shelf life is extremely important.
  • The diversity of different packaging sizes, dosage forms, country presentations and labelling requirements leads to a confusing quantity structure. On the procurement side, one would like to automate this secondary task as much as possible in order to be able to deploy the highly qualified personnel in value-added intensive areas.
  • Campaign planning, optimized set-up sequences, minimum and maximum idle times, combinations of batch and continuous production are all possible within the detailed planning component named ORSOFT Manufacturing Workbench.

As a modular supply chain planning system, typically as an extension of SAP ERP or SAP S/4HANA, the individual planning levels are closely interlinked on the basis of a digital twin and are not isolated individual applications. Planning decisions in one module can also lead to consequences in other planning levels.

Regulatory requirements

The implementation of software in pharmaceutical companies is carried out in accordance with the framework conditions laid down by EU and US authorities (e.g. GAMP4, FDA 21CFR part 11). Compliance with these regulations is an integral part of the project work. Our software is classified as standard software that does not interfere with validation-critical processes in the standard version.

ORSOFT can point to a number of successfully passed supplier audits. Likewise, the special documentation requirements in the project, the execution of validation tests before going live and change processes during operation are best practice.

Authorization concept

ORSOFT solutions as an add-on to SAP ERP use the authorization concept of the SAP ERP system. Each ORSOFT user is identified by his SAP login and receives a assigned SAP authorization. Set audit trail functions in SAP are not affected in their function. The configuration of the software also allows data segmentation per user or user group.