Specialists for IT and GxP
BioMedion is specialized in consulting and Electronic Data Management-Systems (EDMS) in the pharmaceutical, medical technology and life-science industries.
Our target
The target of our solutions is seamless compliance of our customers' IT and data management processes with regulatory requirements (GxP, 21 CFR part 11, OECD eGLP, etc.). At the same time we strive to constantly improve the efficiency and reduce the costs of day-to-day GxP documentation tasks.
From our experience
Our special focus results from our own experience as customers and end-users of IT-systems in GxP regulated organizations. There we were often confronted with inflated consulting projects and solutions that grew so complex that they defeated their own original purpose of streamlining things. At the same time budgets were constantly overrun. Our mission at BioMedion is to deliver tangible benefits within foreseeable time frames and within budget.
How we work
Compliance
With our solutions, customers fulfill all current regulatory requirements (FDA, EU, international). This includes work processes, SOPs, validation and documentation. Future regulatory chances can be easily adapted and integrated.
User friendliness
End-users must be able to easily understand and operate "their" systems. Systems are there to serve the users, not vice versa.
Efficiency
Our solutions pay for themselves. They are designed to simplify and streamline data management and documentation tasks to such a degree as to overcompensate for any additional workload due to new regulatory requirements.
Security
Our solutions are tried and tested to run extremely stable in a wide variety of environments. This offers security and peace-of-mind during daily operations and for audits.
Partners
We see our customers as our partners. Our common goal is a solution which eases the permanent strain of staying compliant. We believe in transparency and know-how transfer so our customers fully own "their" systems. There are no hidden areas, which only the consultant knows about or understands. For us, customer retention is the result of complete customer satisfaction rather than of dependence.