Project ID: 1210 | Branch group: Life Science | Branch: pharmaceutical industry
Documentation for Predefined Solution data warehouse
Project start/end: 17.02.2003 - 31.12.2006
Harmonizing the documentation for a data warehouse project to meet the legal and specific company requirements, with various development teams in an internationally active pharmaceutical group.
To meet the guidelines the Food and Drug Administration (FDA) sets regarding validation (QA), e.g. in terms of traceability, each team's documents need to be standardized in this software project. Furthermore, additional company-specific requirements need to be taken into account. The documentation templates created here help to ensure that all the information regarding all processes is provided and processed in full, for all the process steps in the project.
The members of this subproject are members of the validation team. Their task is therefore to coordinate the entire process, from creating document templates (such as various papers and test plans) through to releasing these documents. The team is the contact for the project members and makes sure that the members keep to the validation plan that is created. Another task is to group together the documents created, to feed these into a specified workflow for release and to ensure that they are processed promptly.