OpenClinica User Manual/SystemValidation

A starting point for system validation

Getting a validated system is a tough process. It is beyond the scope of this wiki to elaborate on it, but if you're looking for a starting point, you can visit several external locations that provide relevant information.

• Toolkit for Clinical Researchers https://www.nidcr.nih.gov/research/toolkit with many Word templates: great starting point to get the general structure!

• The Pharmaceutical Inspection Cooperation (http://www.picscheme.org), especially on in the guidance documents section and with particular attention to the document "PI 011-3 GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED GXP ENVIRONMENTS".

• The Food and Drug Administration (http://www.fda.gov), have a large number of documents, a good starting point would be the drug guidances section.

• The International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (http://ichgcp.net) may also be worth looking at.