Regulatory Compliance
Companies 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. By keeping track of accurate engineering information throughout the organization and by making it accessible to the appropriate people, BlueCielo technology helps to minimize risk, ensure compliance and avoid costly recalls in environments regulated by FDA 21 CFR Part 11, the European Annex 11 of the EU Guide, and Sarbanes-Oxley.
BlueCielo FDA Module is an out-of-the-box business solution that manages current good manufacturing practices (cGMP) engineering documentation throughout the enterprise. The module was developed using standard IT practices and is based on integration with leading technology platforms. BlueCielo's engineering content management solution supports safety, health, environment and quality regulations.
Benefits
BlueCielo Meridian Enterprise's integrated solution provides the following benefits:
- Improved compliance effectiveness
- Reduced validation effort
- Improved document workflow throughout the enterprise
- Lower cost of ownership
