A unified solution, designed for validated environments
Collaboration, data management, and process intelligence across Discovery and Development
Benchling Validated Cloud makes it possible for R&D teams to operate from a unified, validated informatics solution. Research teams can leverage Benchling’s applications for molecular design, registration, and experimentation. Development teams can advance programs using the same solution, within a secure, compliant, trusted environment that can withstand the rigors of regulatory validation.
R&D organizations benefit from greater control and compliance with validated environments, improved tech transfer between research and development phases, and faster assembly of data packages for regulatory filings.
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Application Controls to Ensure User Compliance
- Electronic signature control on all entries, with records becoming locked and non-editable upon signature per 21 CFR Part 11 (U.S.) and Annex 11 (E.U.) regulations
- Complete audit trail with strict versioning of all edits and visible timestamps
- Controlled user access to track and trace engagement and changes within the system
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Dedicated Tenant for Validated Applications
- Greater control, compliance, and GxP compatibility without an impact to work done in non-validated tenant environment
- Controlled, quarterly product release cycles
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Validation Process Support
- Quarterly validation packages that detail the changes and potential impacts
- Validation Plan and Impact Assessment to help determine the risk level of changes to use of Benchling
- Supporting documents to facilitate validation process (IQ, OQ, PQ, UAT)
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Traceability, Accountability, and Data Integrity
- Audit-ready for product development, infrastructure, and security requirements
- ISO 27001 certified for security compliance
- Aligned with ISO 9001 QMS guidance
Benchling Validated Cloud
supports common lab operations
- Experimental design and methods
- Sample and reagent management
- Data collection and results capture
- Team collaboration and review
- Data analytics and analysis
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Our research teams have been using Benchling for years, seen impressive results, and are particularly reliant on the solution's powerful collaboration capabilities. With Benchling Validated Cloud, we can now also meet regulatory compliance requirements and operate within the constraints of our rigid LIMS system. Having one R&D data management solution allows us to to carry forward insights and workflows into the more structured and controlled development processes, giving us a real competitive advantage."Nermin Avdispahic
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