21 CFR Part 11 Compliance with Instron Systems

Do you meet the regulatory requirements set out by 21 CFR Part 11?

Compliance Builder

Failure to meet these requirements in heavily-regulated Biomedical industries can result in:

  • Hefty fines for your organization 
  • Stops in current product production 
  • Delays in product time to market 
  • Lost time and money spent troubleshooting errors in paper records 
  • Inaccurate representation of a device's true quality, clinical behavior, or efficacy

ComplianceBuilder™, a stand-alone, add-on compliance solution, is specifically integrated with Instron’s Bluehill® Software to provide the features necessary to meet the 21 CFR Part 11 requirements.

ComplianceBuilder (CB) allows you to:

  • Predefine user access to test methods, data, and reports
  • Generate electronic records
  • Produce secure, computer-generated, time-stamped audit trails for all electronic records
  • Create unique e-signatures with printed name, date and time, and reason for signature
  • Establish authority checks for e-signatures and record alterations

Download the ComplianceBuilder Brochure

Instron Partners with Xybion Corporation to bring you ComplianceBuilder

Xybion

Xybion is the leading provider of software, services and consulting for global corporations operating in highly regulated industries. Xybion's unique solutions focus on integrated preclinical lab management, early-stage drug discovery, regulatory compliance, GRC, quality management and systems validation. Xybion's combination of software, business process management, services, validation and staffing enables them to cover a broad spectrum of critical business needs for companies and they deliver solutions on a global scale. Xybion's leadership in this dynamic and ever-changing industry has been a cornerstone of their high-value reputation.