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BlueCielo Meridian FDA Module

Manage current good manufacturing practices (cGMP) engineering documentation throughout the enterprise

Companies in the pharmaceutical, biotech and medical device industries are continually looking for innovative ways to bring new products to market faster

It is critical to maximize market success and lower product liabilities by reducing the risk through validation and maintaining compliance with government regulations.

BlueCielo Meridian Enterprise with the FDA Module is an out-of-the-box business solution that manages current good manufacturing practices (cGMP) engineering documentation throughout the enterprise. With the specific FDA capabilities on top of the core BC Meridian environment, safety & health risks are minimized, compliance is ensured and costly recalls can be avoided.

Key Capabilities

  • FDA 21 CFR Part 11 Compliance
  • Secure Access to Engineering Information
  • Lifecycle and Validation Documentation
  • Electronic Signatures
  • Controlled Printing

Key Benefits

  • Improve Compliance Effectiveness
  • Reduce Validation Effort
  • Improve Document Workflow throughout the Enterprise
  • Lower Cost of Ownership
  • Your Bottom Line