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e-crf services & systems validation case studies contacts

validation, documented verification of quality

VALIDATION the phases
 
the service
 
other SYSTEMS
CTDMS
INKDATA Digital Pen&Paper
Safety.DB
InfoTrials
 

VALIDATION > service guide

Lifecycle of a validated computer-based systemThanks to years of experience designing and testing systems for the pharmaceutical world, GM Servizi is able to offer a complete product (Validation Package), which follows the customer at every phase in the lifecycle of a validated computer-based system.

Lifecycle of a system


Validation Master PlanGM Servizi is therefore not only able to define the functional specification, but also complies all the formal procedures necessary to validate recording clinical trials.

GM Servizi sees the validation process as an integral part of a project’s development. The documentation necessary for the validation phase is prepared while the system is being developed, so that a significant amount of time is saved at the final validation. 

GM Servizi is able to support the Customer at every phase of validation, up to and including the construction of a Validation Master Plan.

GM Services provides all validation protocols in English.


 

ISO 9001:2008 e ISO 27001:2005 E- CRF complies with GM Servizi srl Quality Management System certified for ISO 9001:2008
and for Information Security Management System certified ISO 27001:2005
ISO 9001:2008 e ISO 27001:2005