Life Sciences / Pharma

ORSOFT 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 ORSOFT's consultants have become familiar with the specific requirements of the pharmaceutical industry.
Customers are planning over all productions steps with ORSOFT Manufacturing Workbench. Specifics of the industry sector, such as dynamic calculation of set-up times when scheduling and rescheduling orders, are based on a standard and can go live very quickly.

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 integral 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. Therefore, only the interface to the leading ERP system needs validation.
ORSOFT 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.

Authorization Concept

ORSOFT's solution as an add-on to SAP ERP uses the authorization system of the SAP ERP System. Every ORSOFT user is identified by his/her SAP login and will receive his/her allocated SAP authorization. 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.