Green Button Go™ with 21 CFR Part 11 Compliance

Lab Automation with Compliance Control

Digital records have been crucial to expediting information flow in the lab. If you work in a highly regulated lab, tracking and validating electronic records and signatures is required to comply with the Code of Federal Regulations Title 21 for the Food and Drug Administration, also known as 21 CRF Part 11. 

Green Button Go™ Automation Scheduling Software is available in a version that is certified 21 CFR Part 11 compliant so you can maintain security and traceability in the lab while enjoying seamless laboratory automation. The compliant software ensures locked-in access, audit trails, electronic signature logs and other required documentation for using electronic records.

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Key Benefits:

Control Access
  • Set different permission levels for each user account
  • Password protection options include password rules and expiration intervals
Validate Programs
  • Only administrators can establish a validated program or make edits to it 
  • Lock down access to the program so users can’t make changes
  • System users can only run a validated program
Log Electronic Signatures
  • Users can sign a log file or Sign at the end with an electronic signature
  • Signatures on the log files are recorded 
Record Audit Trails
  • Stores audit trail of changes made to a revalidated program
  • Each log-in attempt is timestamped and kept for viewing

Compliance Software Tools

  • Save Validated Program
  • Signatures
  • View Change Log
  • View Security Log
  • View Signature Log

Certified

  • Arbour Group, an independent global regulatory solutions organization serving the life science industry, conducted the third-party review of Green Button Go Scheduling Software

Green Button Go™ with 21 CFR Part 11 Compliance

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