The BlueCielo Meridian FDA module is an out-of-the-box business solution that manages current Good Manufacturing Practices (cGMP) engineering documentation throughout the enterprise. The module also adds specific features to the core data management engine that help minimize risk, ensure compliance, and avoid costly recalls.
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. With the specific FDA capabilities on top of the core BC Meridian environment, safety & health risks are minimized and regulatory compliance is assured.
Key capabilities:
- FDA 21 CFR Part 11 Compliance
- Secure Access to Engineering Information
- Lifecycle and Validation Documentation
- Electronic Signatures
- Controlled Printing
Business benefits:
- Minimize Risk
- Reduce Validation Effort
- Improve Document Workflow throughout the Enterprise
- Lower Cost of Ownership
- Bring Products to Market Faster
- Reduce Costly Errors
- Full Compliance with FDA Rule 21 CFR Part 11
