The investments made by research-based pharmaceutical companies in the development of innovations are higher than in almost any other industry in Germany.
At the same time, however, the pressure to innovate, invest and regulate is growing inexorably, and the increasing integrity and transparency obligations of companies are converting into a new compliance task. For example, companies need to make their processes and structures more transparent, efficient and flexible in order to respond quickly and sustainably to the constantly changing global regulatory environment.
Digitization also brings many new opportunities and is beginning to transform the pharmaceutical and healthcare industry. New and innovative strategies are required to rethink internal processes and the communication channels to consumers, HealthCare professionals and cooperation partners. Digitization enables integration!
In all innovations and investments, integrated IT architectures and highly complex IT systems are an essential component. In most cases, computer system validation is unavoidable. The strictly formal procedure of validation is often seen as a necessary evil to fulfill the obligation to provide proof to internal and external auditors and less as a stringent, transparent procedure to support the continuous improvement of IT functionality in the interest of end users. Since the establishment of the risk-based approach in the validation of computer-based systems, the effort of validation activities can be significantly reduced without, however, increasing the risk for patient welfare in the pharmaceutical industry, production safety or data integrity in return.
What we offer
- Supporting strategy development initiatives including implementation.
- Analyzing and optimizing business processes and organizational structures of business and supporting functions, e.g. Clinical Development, Regulatory Affairs, Medical Affairs and Pharmacovigilance.
- Transferring Standard Operating Procedures and other documents to common workflow and process-based documentation standards (e.g. BPMN 2.0, event-driven process chains).
- Deriving and analyzing IT requirements and supporting the selection or development as well as the implementaion of IT systems.
- Validating computerized systems (CSV) according to GAMP5®.
- Developing flexible and cross-functional business object and data models.
- Managing programs and projects of complex change initiatives.
In close, practical and cooperative partnership, we support you in defining individual strategies and solutions. In this context, we relay on many years of extensive experience and expertise in the pharmaceutical and healthcare sectors.
Our office in Cologne
n: +49 (0)221 / 27 64 59 82
x: +49 (0)221 / 27 64 59 83
- Developing a Process Model according to BPMN 2.0 Standard in Clinical Development22. March 2021 - 1:34
- Developing a flexible and cross-functional Business Data Model in Clinical Operations20. March 2021 - 19:58
- FT2E® (Analysis & Design) in the Corporate Communication Department (Interface: M&A/Corporate Finance)27. March 2021 - 10:59