AmpleLogic RSMS

Regulatory Surveillance Management System

Streamline Regulatory Surveillance with AmpleLogic RSMS

Stay Ahead of Compliance with AmpleLogic’s RSMS System

In the rapidly evolving pharmaceutical industry, staying compliant with global regulations is a constant challenge. AmpleLogic’s Regulatory Surveillance Management System (RSMS) is a robust solution designed to monitor, assess, and manage regulatory changes proactively, ensuring seamless compliance with global authorities like FDA, EMA, MHRA, and other regulatory bodies.

GMP Trends

Monitor Good Manufacturing Practices (GMP) trends to align manufacturing processes with the latest industry standards.

No Objection Certificates (NOC)

Automate the tracking and management of NOCs required for product approvals.

Notice of Concern (NOC)

Identify and address potential compliance risks before they result in enforcement actions.

Cross-Border Compliance Management

Ensure seamless regulatory compliance across multiple markets with a unified platform.

Facing these Challenges?

Frequent Regulatory Updates

Constant changes in global regulations require real-time monitoring and adjustments.

Coordination Among Multiple Stakeholders

RSMS simplifies compliance tracking across various regulatory bodies.

Risk of Non-Compliance

Mitigate risks of penalties, product recalls, and import
alerts with proactive assessments.

Inefficient Manual Tracking

Eliminates manual errors by automating regulatory compliance processes.

Global Regulatory Coordination

Ensures seamless collaboration across different regulatory regions.

Features of AmpleLogic Regulatory Surveillance Management System

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Automated Regulatory Surveillance
Continuously monitors and analyzes regulatory changes from global agencies. Provides real-time updates on compliance requirements.
Impact Assessments for Compliance Risks
Automatically assesses the impact of new regulations on existing processes. Helps companies prepare proactive mitigation strategies to avoid compliance risks.
Compliance Task Management
Assigns compliance tasks to the right teams with real-time tracking and notifications. Ensures accountability and reduces the risk of missed deadlines.
Regulatory Documentation Management
Integrates with Document Management Systems (DMS) to link regulatory changes directly to required documents. Ensures a centralized repository for compliance records, making audits and inspections seamless.
Audit Trail & Reporting
Maintains a detailed record of all regulatory actions taken by the organization. Generates compliance reports for internal reviews, audits, and regulatory submissions.
Cross-Border Compliance Management
Enables companies to manage compliance across multiple regulatory jurisdictions. Ensures consistent adherence to varying regional compliance standards.
System Integration & Mobile Accessibility
Integrates seamlessly with QMS, ERP, LIMS, and other enterprise systems for smooth compliance management. Provides mobile access for real-time regulatory updates and compliance tracking

Why Choose AmpleLogic's RSMS?

AmpleLogic’s RSMS is designed based on critical impact assessments, enabling pharmaceutical companies to track and mitigate compliance risks efficiently. Our system is tailored to address key compliance challenges, including:

483 Observations – Stay ahead of regulatory inspections and avoid observations by ensuring proactive compliance.
Warning Letters – Identify patterns in regulatory warning letters and implement corrective actions before issues escalate.
Import Alerts – Track and manage regulatory import alerts that may affect product distribution across global markets.

Your Pharma Automation Starts Here

We’re here to address your inquiries and assist you in identifying the solutions that best align with your requirements. Here’s why choosing us is your strategic advantage: