Compliance

The products manufactured by DATACHECK are state of the art of applying science to the problems of production of regulated companies.

Their functions can ensure a safer application of quality procedures and control processes of the facto

DATACHECK all applications meet the latest regulatory requirements governing the use of computerized systems in pharmaceutical manufacturing environments and are therefore relevant in terms of GMP.


All our software have the documentation for its validation , documentation is placed particular emphasis on verification of GMP functions identified as critical.


DATACHECK can also provide a complete service for validation of their installation , to optimize time and cost for maintaining the validation status of your systems.

The following are descriptions of the compliance of our documents. application to the two main rules governing the use of systems that require the recording of electronic data and application of electronic signatures.



Conformità ad EMEA - Annex 11



Conformità a FDA - 21 cfr part 11