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Updated by Quality Management on Dec 28, 2019
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AssurX - Quality Management Solutions

The AssurX platform is a versatile system of software solutions for quality management and regulatory compliance to reliably communicate and coordinate information, documentation, and activities across the enterprise. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. No other system is easier to deploy, configure and modify.

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AssurX, Inc.

AssurX, Inc.

The AssurX platform is a versatile system of software solutions for quality management and regulatory compliance to reliably communicate and coordinate information, documentation, and activities across the enterprise. AssurX allows regulated businesses to easily identify and control risk exposure and avoid quality or noncompliance problems while improving workflow. It is uniquely configurable to fit any established or dynamic business requirements. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. Begin with just the solutions and functionality you need now, then implement what you like whenever you’re ready. No other system is easier to deploy, configure and modify.

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AUDIT MANAGEMENT

AUDIT MANAGEMENT

AssurX audit management software allows you to plan, schedule and conduct an audit of any kind. It captures findings and manages the process of resolving them for you.

Automate and streamline your entire audit process from initial planning to tracking trends. New task assignments are automatically generated to process each finding and immediately notify relevant personnel of what they need to do. Any task or finding not resolved promptly can be escalated to a supervising party.

When necessary, the system can also launch corrective actions. With audit management software from AssurX, findings, audit activities, resolutions, and trends are tracked, reported, and stored in a single repository. Intuitive dashboards deliver real-time status, metrics, and clearly identified trends to the parties responsible for managing quality, compliance, and risk.

Once all findings are processed and closed, a final audit report is automatically generated to meet compliance requirements for the FDA, ISO, GxP, NERC, EH&S, EMEA and others.

Compliance Management Software - Quality Management | AssurX

AssurX compliance management software can be easily tailored to meet any initiative or process for any size business entity.

Document Management Software - QMS - Compliance Software | AssurX

AssurX’s document management software automates the storage and management of documents across the enterprise and throughout the document lifespan.

The software provides collaboration tools to let you create, modify, review and distribute documents in a controlled manner—all from a secure central repository that maintains all documents, revisions, and complete document history.

By automating your process with AssurX document management software, you can easily manage, organize and sort documents.

In addition, you can control access to documents with configurable permission and security settings. You can be certain every document is current, and that every revision can be easily processed and tracked. The system alerts appropriate staff of new or revised documents as they are released and records their acknowledgment.

Risk Management Software - Quality Management System | AssurX

Risk Management Software
AssurX Risk Management software makes it possible to increase visibility into how operations relate to specific risks. The result is the ability to improve responding, prioritizing, decision-making and reporting throughout the company.

Easily identify, categorize, document and manage corporate and department level objectives and their associated risks across the enterprise to raise risk awareness and reduce exposure.

By automating risk management process with AssurX, you can easily setup a controls framework for each identified risk so that control testing can be performed to assess effectiveness and mitigation activities can be implemented.

In turn, this reduces risk exposure and ensures compliance. AssurX risk management software facilitates continuous process improvement through controls assessment and mitigation, reducing costs and enhancing compliance to industry standards.

Change Control Management Software - QMS | AssurX

Change Control Management Software
Orchestrate, track and make document changes across all areas of your business with AssurX Change Control Management software. Our automated change control software provides a compliant method that will help your organization manage any type of change.

The software takes change requests and manages the evaluation, planning, approval, implementation as well as the documentation of changes with a closed-loop workflow.

Using industry best-practices, proposed changes that are evaluated, change plans that are mapped out with feedback requests, tasks, reviews as well as approvals are assigned and tracked and approved changes are released and implemented across operations.

With AssurX change control management software, your business can effectively control the change process, no matter where an issue triggering a change originates, and regardless of how many departments the planned change impacts.

Corrective and Preventive Action (CAPA) Software | AssurX QMS

Corrective and Preventive Action Software (CAPA)
Capture incidents from every part of your organization and efficiently manage their resolution – from root cause analysis to action planning, implementation and review with AssurX’s corrective and preventive action (CAPA) solution.

No matter where an issue arises, AssurX’s CAPA software can isolate it and assist you in swiftly managing its resolution. With our CAPA software, you can enhance your action planning with live data, metrics and integrated analytics and track CAPA projects in real-time to better control workflow and costs.

The software gives you a clear oversight of activities, performance, and trends, keeping your corrective and preventive action process streamlined and controlled.

Using AssurX’s closed-loop solution, including effectiveness and compliance verification, you can be confident in your compliance and ISO and GxP performance, while getting the job done right the first time.

Supplier Quality Management Software - QMS | AssurX

Supplier Quality Management Software
Extend quality into your supply network with supplier quality management software to improve product quality and performance.

Monitor suppliers and contract manufacturers, automatically track issues with purchased goods and sub-assembly from receiving through manufacturing and into the field.

With supplier quality management software from AssurX, you can easily detect, inspect and contain quality issues at their source, regardless of how many suppliers and contract manufacturers you have or where they’re located.

Collaborate instantly with suppliers and drive corrective actions to solve problems faster. Automate the qualification and auditing of your supplier base and collect real-time metrics that calculate supplier scores based on performance so you can sustain the highest standards across your network.

AssurX supplier quality software lowers the cost of manufacturing by reducing rework and bad shipments while ensuring quality at the source.

Patch Management Software - Quality Management Solution | AssurX

Patch Management Software
A HARMONIZED APPROACH TO IT/OT PATCHING

The increasing complexity of industrial systems combined with greater automation creates an integrated network IT, OT and IoT systems. This convergence requires cybersecurity, data privacy, safety and GRC to align with business objectives in a way that eliminates the siloed approach to technology management and asset patching.

AssurX Patch Management is a configurable software solution that solves the security challenge of managing asset patching across IT, OT and IoT infrastructures. One solution presents evidence of risk mitigation and demonstration of patch compliance to auditors, internal and external stakeholders. Originally designed for the stringent cyber asset compliance needs of the Energy & Utilities industry, the software enables the process-based management of all networked assets regardless of classification.

Patch Management enables IT and OT technology managers to create a single, unified patching process aligned with corporate and regulatory compliance expectations. The result is a collaborative, proactive cyber asset “command center” driven by a controlled set of workflows and sub-processes. Patch Management is well suited for data center infrastructure management (DCIM) strategies for oversight of interdependent systems across IT and facility infrastructures.

INCREASE THE VALUE OF SECURITY SOLUTIONS THROUGH INTEGRATION

Patch Management integrates with other solutions in the AssurX platform and other third-party monitoring and management solutions to provide a single point of insight into the state of enterprise patching activity.

Integrate with the AssurX platform for corrective actions/mitigation plans, change management, document management, training management, and others. Integrate with patch discovery and monitoring services for a full view of vulnerability and risk exposure.

Integrate with automatic patch installation software to speed patch deployment. All deployment data becomes part of an indisputable master record driven by a single system of controlled processes.

Complaint Management Software - Quality Management System | AssurX

Complaint Management Software
Automate and streamline the complaint lifecycle from product event intake through investigation, root cause analysis, corrective action and reporting to regulatory agencies.

Based on compliant industry best practices for complaint handling, AssurX’s complaint management software guides users through proper processing, documenting and reporting of every complaint. The software logs product events from all sources (CRM, phone, email, website, internal, etc.) then centrally manages the process as reporting requirements are assessed; investigations conducted, and follow-up activities are assigned and tracked.

When required, the system can automatically launch corrective actions and electronic regulatory reporting. The software comes with fully compliant audit trail and electronic signature functionality.

Using automatic task assignment, escalation, and notifications to keep the process efficiently moving, AssurX complaint management software creates an ironclad closed-loop system that ensures all product issues are properly handled and reported in a timely manner.

Customer Quality Management Software - QMS | AssurX

Customer Quality Management Software
Customer quality management software from AssurX improves responsiveness and customer satisfaction while ensuring consumer and partner reported quality issues are always properly documented and effectively resolved.

Automate, centralize and streamline the processing of customer-reported product events including complaints, returns (RMAs), field service and product improvement requests to resolve customers’ issues in a reliable manner. The software receives customer-reported events at intake, drives response workflows based on event type and severity, and initiates and manages corrective actions (CAPAs) when required.

With AssurX Customer Quality Management software you can automatically track the investigation and resolution of customer issues—correlating them with production, suppliers or other quality issues—and document the entire process in a closed-loop workflow that is based on industry best practices.

Using automatic task assignments, escalation and notifications the software keeps the process moving efficiently and ensures all customer issues are properly handled. It collects information about related events and identifies trends across the organization and supply chain to help prevent future quality issues.

Manufacturing Quality Management Software (QMS) | AssurX

Manufacturing Quality Management Software
Streamline and automate the tracking, documenting and resolution of manufacturing-related quality incidents, such as non-conformances, deviations, defects, failures and exceptions with AssurX manufacturing quality management software.

Manufacturing quality management software from AssurX efficiently automates the processing of quality issues from detection through investigation, disposition, corrective actions and change control in a single system.

With AssurX manufacturing quality management software, you can ensure quality issues from any source are logged, root causes are investigated across operations – even into the supply chain – and corrective actions and systematic changes are automatically launched, documented and implemented.

Regardless of where an issue originates or how many departments the resolution touches, the AssurX system lets you control the process with efficiency and consistency.

Training Management Software - Compliance Management | AssurX

Training Management Software
Training management software from AssurX ensures your personnel are always effectively prepared for the job, all training is properly documented and histories are accessible, auditable and correctly reported, when necessary, to meet quality management and regulatory compliance requirements.

Take charge of all training requirements, activities, materials/courses and histories throughout your organization. With AssurX training management software, your company can quickly identify “who-needs-what” training even in complex, changing environments.

Training tasks can be automatically launched based on events in the other software systems, and all associated training activities are systematically managed and recorded to keep your company efficient and compliant with regulatory requirements.

When paired with AssurX Document Management, you will not only reduce paper and messy distribution, you can be sure that users are always accessing and training on the correct version as each new or revised document is ready. And since due dates are automatically tracked, you can be certain all training activities are completed on time and that training histories are updated on the go.

  • The AssurX software platform is a highly versatile automated Quality Management System (QMS) and Regulatory Compliance Management Software used to improve quality and compliance, streamline workflow, control risk and better manage any enterprise. Our QMS and Regulatory Compliance Management software puts quality at the foundation of your enterprise rather than relying solely on your quality assurance team. The AssurX system gives you complete control of activities and data, so you know immediately when a quality or regulatory compliance issue arises. AssurX efficiently gets the right information to the right people, so they can effectively evaluate, prioritize and resolve issues. AssurX spans across every department in the enterprise, encompassing the entire product lifecycle, and providing an essential quality management solution for highly regulated and ISO compliant manufacturers.

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