A unified solution, designed for validated environments
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
"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."
