Regulated Manufacturing Technologies & Strategies

Transforming regulations into opportunities

There is a high cost for being out of compliance. Production can come to a stop while issues are addressed, and that gives the competition an opportunity to get in front of you and stay there.

As a strategic partner, we help you navigate current regulations impacting manufacturing and prepare for future ones, build processes to automate compliance and traceability, and enable audit trails to make it easier—even instantaneous—to demonstrate adherence to agencies and officers alike.

Specific tools for specific rules

Through strategic implementation ERP solutions for centralized data and automated workflows, you can better ensure your manufacturing business adheres to FDA and ISO standards. Additionally, data analytics and AI systems enable predictive quality and risk management, while robust cybersecurity tools help protect sensitive data (crucial for ITAR and CFR Part 11). We empower businesses with scalability and accessibility, providing both the strategies and technologies to streamline compliance efforts across your enterprise.

Enabling enhanced transparency and traceability

With unique identifiers, such as barcodes and RFID tags, integrated with ERP systems, we enable you to capture data at each production stage, linking components to finished goods and tracking their journey. Electronic batch records (EBR) provide a digital history of manufacturing—from the procurement of raw materials to last-mile delivery. We enable the

swift identification and isolation of defective products for recalls, facilitate root cause analysis, and provide a documented history for audits.

Sustaining compliance

In the face of an ever-changing regulatory environment, you need a partner who offers expertise in implementing and managing ERP and other business systems specifically tailored to regulatory needs (FDA, ISO, CFR Part 11). We provide continuous support and updates to keep systems aligned with evolving regulations, freeing your teams to focus on core operations while ensuring sustained compliance and minimizing potential fines.

Protecting data, ensuring continuity

A major step in staying compliant is keeping up with the outside world, and the endless and variable threats it can present. We deliver robust security measures like intrusion detection, firewalls, and data encryption to safeguard sensitive data, provide proactive threat monitoring, and ensure swift action against attacks, minimizing downtime. Our goals are ensuring business continuity, protecting operations, and ultimately preserving your business’s reputation and financial stability.