Qstep SRL

qstep is a new consulting company specialized in computer system validation, data integrity and it compliance in gxp environment we strategically and practically support life science companies in their it compliance projects providing the following services • ongoing adaptation of risk based computer validation approach to current regulatory expectations • computer validation of it systems • laboratory systems validation • process control systems validation • csv best practices • documentation templates • user requirements and process mapping • data migration verification strategy and execution • system testing (unit & integration tests, uat) • validation test planning, execution & documentation • best practices procedures to maintain the validated status • change management • periodic reviews we work in team with the client in the implementation of a cost effective and feasible validation strategy that assure data integrity, approaching the regulatory compliance with a robust ri