In the area of Life Sciences, quality assurance plays a central role in the complete product life cycle, i.e. from development, through trials, to the production of medications and medical ingredients. up to data is aware of the ensuing high standards and requirements that are also expected from suppliers. With over 15 years experience in the chemical-pharmaceutical field up to data can offer a comprehensive range of services to facilitate the implementation of your software solutions in conformance with cGxP.

up to data offers the following validation services based on the ISO 9001 and ISO 27001 certified Quality Management System:

• Coordination and production of all qualification documents (risk analysis, test plans and protocols for DQ, OQ, PQ phases, as well as qualification plans and reports).
• Planning, implementation and evaluation in line with EG-GMP Guidelines Annex 15, and coordination of various qualification projects.
• Support for Computer System Validation according to CFR 21 Part 11, EG-GMP-Guidelines Annex 11 in consideration of GAMP-Guidelines