Navigating the complexities of global regulatory entities and requirements can be difficult, and the penalties of noncompliance – lost time, staff attrition, fines, recalls, or worse – can slow down productivity in even the best-run laboratories. OneSource Compliance services can be your partner to get you back to focusing on your core activities. With our consultative approach we can offer gap analysis or inspection readiness and provide comprehensive trainings.
With Compliance Services from OneSource, you can address your challenges head-on. You’ll have access to a library of custom qualification documents and methods, and a team of trusted consultants with real expertise in qualification, requalification, risk management, and remediation. It’s a multivendor approach that frees your scientists to concentrate on research, discovery and throughput, allowing you to meet business and regulatory objectives. This is compliance made simple.
By consolidating with one provider – OneSource - and harmonizing your protocols under a single Universal Operational Qualification framework, you’ll have a comprehensive, automated approach to testing, documentation and compliance, streamlining processes across all major models of laboratory instrumentation, regardless of vendor.
We can offer temperature mapping and dissolution testing. OneSource provides GLP/GMP-compliant thermal mapping studies, including open-door destabilization testing using test equipment calibrated to international standards. With OneSource, you get storage space temperature mapping validation done right – the first time. And fully automated reports and advanced techniques such as wireless temperature probes reduce human error and damage to instrumentation. Our OneSource service teams are staffed with engineers and consultants who know the ins and outs of dissolution testing. Our teams have contributed to the FDA/USP working group on vibration limit evaluations and settings. We offer mechanical qualification and chemical validation services that meet the very latest U.S. and E.U.
Analytical method requirements that span the full lifecycle — from method development and validation to method transfer services — can be time-consuming activities. Leverage the OneSource team to streamline lab workflows and boost scientific productivity with data integrity assessment and methods to establish quality control procedures that support reliable research data including method validation with USP<1225> and ICH Q2 as well as Metrology and Calibration services. 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 analysis spans their full lifecycle to keep you on the path to an efficient, productive and compliant lab.
