“We use AssurX to log quality incidents related to vendors, co-packers, plants and distributers. We’re also logging issues related to health, safety and environmental incidents at our plants.”

Delivering the Highest Food Quality, Safety and Efficiency for the Food and Beverage Industry

Achieve the highest food and beverage quality and compliance while maintaining production efficiency and profitability. AssurX provides fast, detailed visibility and traceability of product quality and safety from the supply chain to the consumer, as well as a means to easily comply with regulatory standards from the FDA, USDA, HACCP and others.

AssurX provides an end-to-end quality and compliance management system that manages all product quality, safety or compliance issues across the production processes and into the supply chain—delivering a tighter grip on materials and the ability to prevent small production problems from becoming expensive recalls.

The system automatically creates compliant audit trails and gathers the detailed data into a central repository, reducing the cost and burdens of regulatory compliance.

AssurX give you the ability to easily trace and access data, even at the granular level, and use that information to improve efficiency and control to protect your your brand, your market share and your industry reputation.

AssurX Quality Management System Software Features

Insight

Early detection of product quality or safety problems and the ability to correlate them with the root causes to avoid recalls, reduce product waste and downtime, and increase yields and consistency.

Effectiveness

Better manage overall supplier quality and ensure higher, more consistent quality of goods and materials supplied.

Steamline Workflows

System includes predefined workflows, ready-to-use or modify, for tracking and resolving food safety or other noncompliance incidents.

Efficiency

Automate and streamline the disposal of defective products and improve overall return/recall management.

Automated

Process and automatically document food safety and compliance issues with comprehensive, easy-to-use tools.

Electronic Approvals & Signatures

Require compliant electronic approvals for any key process steps, set due date on signatures requests and automatically notify approvers of upcoming or past due deadlines.

Identification

Track and isolate food quality or food safety issues down to individual lots or batches, to quickly resolve issues before they become bigger problems.

Simplicity

Conduct easier internal and external audits. Automatic creation of audit trails with compliant e-signatures, and quick access to detailed data with the click of a button.

Automatic Documentation

Automatically document all food safety, quality incidents and resolutions through investigation, Aroot cause analysis, corrective actions, verification and closure.

AssurX QMS Software for the Food and Beverage Industry

Corrective and Preventive Action (CAPA)

Perform efficient and effective root cause analysis, reduce product defect levels, and increase product yields with AssurX’s automated, streamlined CAPA process. Issues are investigated, root causes identified, corrective/preventive actions planned and implemented across operations, and then evaluated for effectiveness. Control costs, and improve your products while meeting regulatory requirements for closed-loop quality management. Because it’s fully integrated with other quality related processes such as audits, nonconformance, customer complaints, etc., no matter where an issue originates, the system can effectively manage its resolution.

Supplier Quality Management

Monitor quality and safety of supplied ingredients and materials with the ability to automatically track supplier/partner HACCP and ISO22000 compliance and overall performance. AssurX‘s solution offers instant collaboration and visibility across your supplier network to vastly improve product quality. No matter the number or location of your suppliers or contract manufacturers, the software lets you quickly detect, inspect, track and contain supplier related quality and food safety issues quickly and correct them before they become bigger issues. Collaborate in the resolution of issues with suppliers, and rate and document overall supplier performance.

FDA and Other Compliance

AssurX integrates food safety, regulatory and quality management programs into a single system providing reliable traceability and control. The software delivers automated regulatory compliance with built-in e-signatures and automatically documented audit trails that meet regulatory requirements. The entire system is built to meet FDA, EH&S, and USDA requirements. It also meets all ISO, Six Sigma, and lean manufacturing standards and conveniently stores all the detailed information in an easy to access repository for quick responses to audits or complaints.

Manufacturing Quality Management

Globally document, track. and resolve manufacturing related quality issues such as nonconformance, deviations, defects, incidents, exceptions, and change requests—from initiation through disposition, corrective action and change execution. Effectively manage returned merchandise and improve both customer service and supplier and trading partner management. This closed-loop system is fully integrated with other quality and compliance processes and follows ISO 9000 and GMP standards for best practices. Track trends, cycle times and costs to facilitate root cause analysis and improve efficiency.

Complaints Management

The AssurX Complaints Management system provides a ‘best practice’ process for managing the entire event life cycle from complaint intake through investigation, and root cause analysis. It features management dashboards and strong audit trail reports and controls.

Audit Management

AssurX’s solution delivers a comprehensive audit management process and adheres to industry current best practices for closed-loop findings; closure, task assignments and escalation. Audits are conducted after being planned and scheduled, findings are classified and follow-up is assigned to the right area managers. Corrective actions can be automatically launched and their resolution documented. After follow-up actions are addressed, a final report is issued and routed for complete closure. Reports and dashboards provide live data for instant status and metrics.

Document Management

Built-in, easy and effective management of the entire document life cycle from change orders through release approval, dissemination and training. Get rapid, easy, and secure access to current and accurate documents at all times. AssurX Document Management allows businesses to improve the visibility of process changes, reduce risk and labor costs associated with the use of erroneous and outdated procedures, and demonstrate regulatory compliance to inspectors.

TRAINING MANAGEMENT

Take charge of all training requirements, activities, materials/courses and histories throughout your organization. Quickly identify “who-needs-what” training even in complex, changing environments. The AssurX solution ensures your personnel are always effectively trained for the job, all training is properly documented and training histories are accessible and auditable.

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Summary

Article Name

Food & Beverage Industry - QMS - FDA Compliance | AssurX

Description

Achieve the highest food and beverage quality and FDA, USDA, HACCP compliance while maintaining production efficiency and profitability.

Author

AssurX, Inc.

Publisher Name

AssurX, Inc.

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