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Data often arises simultaneously from multiple applications, be it from financial systems or from technical
systems such as the quality control of products. It makes sense to consolidate and to evaluate the data as
a single entity, regardless whether it deals with accumulated financial data for the control of the company,
or whether it deals with the quality data of various production stages, in order to optimize the production.
Data will be standardized, processed and saved in such a way, that it is available on a broad basis and can
be researched, condensed and statistically evaluated by the users themselves. This now enables companies to
draw important conclusions from the data.
Examples of Application for Life Science Companies
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Integration of quality data of all production stages as a base for Six-Sigma production
improvements (PAT - Process Analytical Technology). Statistical evaluation with multivariate procedures. |
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Adverse Events: Storing the adverse events in data cubes. Statistical evaluation, ad hoc analyses. |
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Statistical analysis of data and measurement data. |
Our offer
We advise, plan and implement data analysis and business intelligence projects, specifically
for GxP areas of the pharmaceutical industry, in which we posses extensive know-how.
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Business Intelligence in GxP Areas
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Business Intelligence Systems which are applied in GxP
relevant areas must comply with FDA and/or EMEA regulations.
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Data analysis and business intelligence systems are to be created
and validated in accordance with GAMP Standards and/or the V-Model. Data must be managed in
compliance with 21 CFR Part 11 and the computing process must be completely reproducible and traceable.
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We are qualified in these areas and provide support in the planning and realization of such undertakings.
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