OneSource® Software Validation and Qualification keeps your computer systems compliant with regulations.
Computer System Validation
Our computer system validation services are based on 21 CFR Part 11 (electronic records & electronic signatures) and GAMP5 ("risk based" approach & V Model documentation). All validations are based on "intended use" and "environment," which is customized based on user requirements (URS). Validations range from full validation for new systems to change control validation for existing standalone and/or enterprise systems.
Software Instrument Qualification/Operational Qualification
We provide several IQ/OQ offerings for your software
- Software IQ/OQ for all PerkinElmer ES (enhanced security) version instrument software products such as WinLab6 ES, Nexion ES, Spectrum10 ES, etc.
- Software IQ/OQ for Waters Empower™
Software Validation & Qualification
- Validation and qualification for computer systems and software
- Streamlines your CSV projects and supplements your own CSV deliverables