Regulatory Compliance

Optimize your profitability while assuring compliance with global, local and industry-specific regulations.

Owner operators are continually looking for ways to gain a competitive edge in global markets. In order to maximize market success and lower product liabilities, they must maintain compliance with increasingly strict safety, health, environmental and quality regulations – or risk losing their license to operate.

Achieving compliance with internal or external regulations and standards requires a solution that maintains data integrity. But information management alone is not enough. Maximizing profitability in stringently regulated environments requires a system that prevents errors, delivers notifications in the event of deviation, and ensures full traceability. Changes must be managed, logged and auditable. User access must be authenticated and critical information must be protected. In addition, the appropriate security measures must be integrated into workflows for approval, rendition and distribution.

BlueCielo solution for regulatory compliance

Full control – easy compliance

BlueCielo’s solution for regulatory compliance provides comprehensive protection, ensuring data consistency and completeness, while assuring compliance with environmental, health and safety regulations.

Our solution manages current Good Manufacturing Practices (cGMP) engineering documentation throughout the enterprise, helping to minimize risk, ensure compliance at every stage, avoid costly recalls in environments regulated by FDA 21 CFR Part 11, the European Annex 11 of the EU Guide and reduces the total cost of ownership. We offer an extensive history log and audit trail for full proof of control at any time. Compliance with all relevant external regulation and internal policies and procedures is supported at all stages, and role-based access enhances protection for intellectual property.

BlueCielo offers 21 CFR Part 11 compliance by providing secure access to engineering information, lifecycle and validation documentation, electronic signatures, controlled printing and many more industry-specific features in an out-of-the-box solution for FDA compliance.

“We have realized the anticipated efficiency gains in our capital projects. BlueCielo’s life sciences experience and quality-based implementation processes contributed to the successful system validation.”
Name withheld for privacy, Pharmaceutical company
“Two weeks after the launch of BlueCielo Meridian, the ISO people came to perform an audit. They were extremely satisfied once we had demonstrated our new data management system.”
IT Intermediary, Eneco Energie
“BlueCielo Meridian provides Kaneka with a regulatory compliant system to manage the asset lifecycle and management of changes projects.”
Engineering Project Manager, Kaneka

The single solution to maximize profitability

Optimize your profitability

A single solution to increase return on assets

Maintain asset data integrity

Optimize multi-site asset performance in regulated environments for operational excellence