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.
vc-2.png
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.

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

Validated_cloud.png

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."
Image
Nermin AvdispahicQuality Control Manager, New England Biolabs

Join over 200,000 scientists using Benchling to power their biotech R&D

Helix Image