Services for Life Science
BIO-IT.EU was established in 2008 by Dipl.-Ing. (FH) Ludwig Wiesent.
Target audience
Pharma and Biotech companies
Main Scope
Shape data into a modern and reliable data architecture
Objective
Research and production data benefits from a data-driven approach
- An important improvement are standardized API's between systems. to accelerate workflows
Since the enrollment of ISO9001 and follow ups, research and production of drugs need to be supervised and certified. E. g. under the FDA 21 CFR part 11 and others ...
Keywords
CSV, CSA, GAMP5, CSV, Scientific Data Management, FDA 21 part11, 210, 211, 820, ISO13485, EMA Annex 11, Risk Management, Data Science, Data Migration, SAP Basics
Enterprice platforms: LIMS, ELN, CMS, eDMA, MES
Software from Dotmatics, IDBS, Thermo Fisher, Perkins Elmer
Tools: JasperServer, BIRT, R, MathLab, Linux, SQL Sever, Oracle
Scripting in PERL, vBasic, SQL, Collibra, SAS LSAF
Education
Dipl.-Ing (FH) Chemieingenieur
Certificate of the Postgraduate Program Bioinformatics
S k i l l s
Scientific Data Management
Computer System Validation
Data Integrity
Data Governance
