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WHITE PAPER

Considerations for using Benchling as a GxP system

This white paper discusses considerations for companies planning to use Benchling as a good quality system (GxP) in a regulated environment. It also details Benchling’s strict security controls, 21 CFR Part 11 compliant product features, comprehensive validation support, and internal quality systems.

Benchling validation and qualification approaches - GxP
OVERVIEW

Regulated industries typically require companies to comply with Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices (“GxP”), which extend to computer systems used in regulated processes. This product sheet discusses considerations for companies that plan to utilize Benchling solutions in R&D workflows that fall under GxP regulations and require computer systems validation.

Topics include:

  • Benchling’s approach to enterprise security, infrastructure security, and the standards such as ISO27001 and the Global Data Protection Regulation (GDPR)
  • A review of capabilities found in Benchling software applications that support GxP compliance
  • Considerations for establishing Benchling as part of a validated computer system
  • A review of Benchling’s Quality Management System including risk and change management, and Corrective and Preventive Action (CAPA)
Download White Paper