Qstep srl

Qstep is a consulting company specialized in Computer System Validation, Data integrity, Digital Quality Assurance, IT compliance and Digital Governance 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 risk analysis. Our service in DATA INTEGRITY are: • Data Integrity Policy specification • Computer System Validation Strategy • 21 CFR Part 11 & EU GMP Annex 11 Assessments • 21 CFR Part 11 Inspection Readiness Projects • Data Integrity Historical Verification • Continuous Monitoring Procedures for Data Integrity We share our knowledge with the client and we organize training program on CSV, Data Integrity and IT compliance tailored on the customer needs and environment.