Overview

A unified solution, designed for validated workflows

Access compliance controls to maintain user compliance and ensure GxP readiness with a dedicated tenant. Drive faster assembly of data packages for regulatory filings and efficient tech transfers with the Benchling Validated Cloud.

Ensure user compliance with application controls

Verify correct execution of GxP workflows with in-application controls.

• Use e-signature controls per 21 CFR Part 11 and Annex 11
• Review audit trail of all edits with visible timestamps
• Track system changes with controlled user access

Ensure GxP readiness with a dedicated, validated tenant

Deploy a dedicated, validated tenant to keep robust control over GxP workflows, with maximum flexibility for non-GxP research teams.

• Separate GxP and non-GxP work 
• Cut unnecessary GxP burden on non-GxP research work
• Receive updates in controlled, quarterly releases

Receive expert support throughout the validation process

Access all the necessary technical expertise and documentation to guide you throughout the validation process, including IQ and OQ.  Receive quarterly validation packages detailing changes, and determine risk level of changes with impact assessments.

Improve data integrity, accountability, and traceability

Pass third-party and regulatory audits by complying with the latest regulatory, security, and quality standards.

• Stay ready for third-party audits 
• Comply with ISO 27001 security standards
• Align with ISO 9001 QMS guidance

Capabilities

Controlled, validated tenant

Deploy a dedicated tenant to manage GxP workflows and give teams control to mitigate compliance risks.

Compliance functionality

Stay compliant with software controls that meet the latest regulatory, security, and quality requirements.

Validation and audit support

Access all required documentation and technical expertise to get validated quickly and be audit ready.

Structured, queryable data

Capture experimental data from GxP studies in structured templates and results tables that can be queried or searched easily.

Harmonized data model

Keep consistent sample naming, ontology, and hierarchy across R&D with a harmonized data model.

Collaboration and workflow management

Coordinate sample submissions, data handoffs, and results reporting between GxP teams.