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FDA/GMP Compliance

FDA and GMP Features in SAMPLIFY Script

Tools and features to achive traceability and FDA 21 CFR Part 11 compliance

Application

  • Drug Discovery
  • Quality Control
  • for all SAMPLIFY Script applications

Features & Benefits

  • Improve the process stability and traceability
  • Use Cases and User Role Models
  • Integration in LIMS or other IT systems
  • Excel® integration
  • Signed methods
  • Easy integration of external devices

Details

  • User management and password protection
  • Signed methodes, which cannot be changed
  • Report generation as a PDF or JPEG after every run
  • Audittrail
  • Login trail all activities database
  • APP History indicates all changes and version management