A unified solution, designed for validated environments

With Benchling Validated Cloud, R&D teams share key data to accelerate time-to-market while meeting compliance requirements.
Overview
Application controls to ensure user compliance
  • Use 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.

  • Track and trace engagement and changes within the system with controlled user access.

Dedicated tenant for validated applications
  • Gain greater control, compliance, and GxP compatibility without an impact to work done in non-validated tenant environments.

  • Controlled, quarterly product release cycles

Validation process support
  • Quarterly validation packages detail changes and potential impacts.

  • Validation Plan and Impact Assessment help determine the risk level of changes to use of Benchling.

  • Access supporting documents to facilitate the validation process (IQ, OQ, PQ, UAT).

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

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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
"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."
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Nermin AvdispahicQuality Control Manager, New England Biolabs

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