Rely on OneSource® Laboratory Compliance Services to give you greater confidence knowing that your lab is operating within global regulatory requirements. By consolidating with one provider and harmonizing your protocols under a single Validation Master Plan (VMP), our OneSource Universal Operational Qualification (UOQ) framework delivers an automated approach to testing, documentation and compliance, streamlining processes across all major models of laboratory instrumentation, regardless of vendor.
OneSource® offers both automated and traditional paper qualification methods and our standard recommended OQ protocols can be customized to your specifications. Our service engineers test instruments against approved specifications and provide final qualification reports using easy-to-review layouts in paper and secure electronic format.
Suited for any size laboratory, our instrument qualification offerings will keep you on the path to an efficient, compliant lab.
OneSource® provides several IQ/OQ offerings for software qualification and the assurance that instrument data is reliable and consistent for the highest quality results. OneSource validation solutions streamline and supplement your CSV projects and your own CSV deliverables.
We provide several IQ/OQ offerings for your software:
OneSource® Computer System Validation (CSV) assists in the planning and implementation of validating computer systems and ensures validation methodology meets regulatory requirements.
Our services are based on 21 CFR Part 11 and GAMP5 ("risk based" approach & V Model documentation). All validations take into account "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.