Industry Competence

OR Soft has been working with companies within the pharmaceutical industry since the company’s establishment in 1990. We have developed many software functions in the course of projects for our clients and steadily expanded our range of products. Through this work we have become familiar with the specific requirements of the pharmaceutical industry and have learned to satisfy them reliably.

Regulatory Requirements
The implementation of software in pharmaceutical companies is carried out in accordance with the framework conditions determined by EU and US authorities (e.g. GAMP4, FDA 21CFR part 11). Compliance with these regulations is an integrative component in the project work. Our software is classified as standard software that does not, in its standard form, interfere with processes that are critical to validation. Only the interface to the leading ERP system therefore needs validation. OR Soft can refer back to many successful supplier audits and has implemented special document requirements for projects, execution of validation tests before production and change processes during current operations many times before.

Authorisation Concept
OR Soft solutions as an add-on to SAP ERP uses the authorisation system of the SAP ERP System. Every OR Soft user is identified by his SAP login and will receive his allocated SAP authorisation. Audit trail function settings in SAP are not limited in their function. The configuration of the software also allows data segmenting per user and/or user group.

Batch Processes
Administration of the logistics processes on a batch basis is standard in the pharmaceutical industry. OR Soft uses the entire logistical production, including information on a batch basis, on the stock, order or batch object level.

Shelf Life
Many pharmaceutical processes are characterised by temporary use of materials and products. This is especially valid for new offers and bio-technological materials. We use the allocated shelf life in order to fulfil reporting and logistics requirements. This allows, e.g. the early identification of batches that are close to expiration already in the planning process.

capacity planning

back next