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.