Documentation

A working GXP-IT environment needs extensive SOP's with expertise in both GXP and IT knowledge

The preparation of quality SOP-system saves time and reduces costs in the later operation of the IT network. When the evolving nature of the IT has been taken in consideration in setup of the SOP-system, later upgrades and updates are done with minimal cost and work. Sometimes the solution what is best for IT is worst for GxP regulations (21 CFR part 11, Vol 4 Annex 11), therefore expertice in both fields should be used.

Our consultants have more than decade of experience in setting up quality GXP-IT documentation for various companies.

We can draft basic SOP system for start-up GXP company to follow, to avoid unnecessary costs and development time in the future also ensuring that data quality has been considered from beginning. For established companies, reviewing and updating the documentation records and procedures before major inspections provides confidence to fullfill the regulatory requirements.