Your lab needs to follow a rigorous validation methodology to satisfy regulatory authorities. OneSource offers project and program based computerized system validation (CSV) support to meet your needs and ensure that instrument data is complete, consistent and accurate. OneSource CSV solutions promote efficiencies where applicable, risk based and least burdensome approaches while always ensuring requirements of validation including Part 11 are met with a high degree of data integrity.
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OneSource CSV services ensure your lab’s computerized systems including hardware and software, meet regulatory requirements.
These services range from full validation or commissioning for new systems to change-control validation for existing standalone and enterprise systems. Our team follows GAMP 5 and aligns with your site's specific policies and procedures as they relate to the SDLC.
At the same time, we provide a range of software IQ/OQ offerings, including enhanced security instrument software products such as WinLab 6 ES, NexION® ES, Spectrum® ES, and more. And there’s special support available for Waters Empower® software.
The time and resources needed to meet global requirements for regulatory inspections and remaining compliant are at odds with laboratories’ needs to increase productivity and reduce operating costs. Now you can harmonize documentation across all models of lab instruments, regardless of the manufactu ...
