FactoryLogix Regulatory & Customer Compliance is a specialized module within Aegis Software’s FactoryLogix MES platform. It is designed to help manufacturers meet stringent regulatory and customer-specific compliance requirements by embedding traceability, documentation, and process control directly into production workflows. The solution supports a wide range of industry standards and enables manufacturers to maintain audit readiness and product integrity across global operations.

Features

• Complete Traceability: Tracks materials, processes, and personnel involved in every step of production.
• Automated Documentation: Generates and stores compliance records, certificates, and audit trails in real time.
• Process Enforcement: Ensures that only authorized and validated processes are executed on the shop floor.
• Electronic Signatures & Approvals: Supports digital sign-offs for critical process steps and quality gates.
• Audit Readiness: Provides instant access to compliance data for internal and external audits.
• Customer-Specific Requirements: Configurable workflows and documentation to meet unique customer mandates.
• Non-Conformance Management: Identifies, logs, and resolves deviations with structured workflows.
• Change Control: Tracks and manages engineering and process changes with full version control.
• Integration with MES: Seamlessly connects with FactoryLogix modules for execution, quality, and logistics.

Benefits

• Regulatory Compliance: Supports standards such as ISO, FDA, AS9100, and others with built-in controls.
• Reduced Risk: Minimizes the likelihood of non-compliance through proactive monitoring and enforcement.
• Improved Audit Outcomes: Real-time access to traceability and documentation simplifies audit preparation.
• Customer Satisfaction: Demonstrates commitment to quality and compliance, enhancing trust and retention.
• Operational Efficiency: Automates compliance tasks, reducing manual effort and errors.
• Global Standardization: Enables consistent compliance practices across multiple sites and regions.
• Data Integrity: Ensures secure, tamper-proof records with electronic signatures and audit trails.
• Continuous Improvement: Leverages compliance data to drive process enhancements and reduce defects.