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“AssurX is the most flexible and intuitive solution on the market. It is also the most user-friendly from both the end user and administrative perspective. AssurX is 5–10 years ahead of their competitors.”

genzyme Medical Device Manufacturing company selects assurx qms

Quality Management & Compliance for Medical Device Manufacturing

Managing industry best practices to drive product innovation and patient safety
AssurX medical device manufacturing quality management software (QMS) is designed to balance the complexity of global quality management and regulatory requirements while maintaining a high level of flexibility to adapt to continual industry and operational changes.

Successful life science companies utilize AssurX’s seamlessly integrated software to centrally monitor, manage and improve their quality and regulatory compliance-related processes across all operations and product lifecycle.

AssurX software is designed to support current good manufacturing practices (CGMP) and medical device regulations including FDA 21 CFR part 820, European Union Medical Device Regulation (EU MDR), and ISO.

In addition, AssurX is designed to comply with U.S. Department of Health and Human Services (HHS) and HIPAA patient privacy regulation.

AssurX platform and preconfigured solutions provide U.S. Food and Drug Administration 21 CFR Part 11 validated processes for the successful management of QMS processes including; complaints, supplier quality, document control, CAPA, change management, audits, and training.

A state of control and proof of compliance is maintained continuously in one central, securely accessible system.

Single Platform

One system of seamlessly connected solutions to improve quality, ensure compliance, manage risk and streamline workflow.

COMPLIANCE BUILT-IN

Every solution built for FDA, ISO and cGXP. Seamlessly integrated electronic medical device reporting.

Streamlined Activities

Automatically orchestrate and track activities, share data and communicate information to the appropriate parties.

COMPLETE TRANSPARENCY

Dashboards provide live, clear views of coordinated activities and information across all areas of the business.

THE EFFICIENT MANAGER

Manage operations while detecting, correcting and preventing potential issues.

EFFORTLESS STABILITY

Simple to deploy, configure, use and modify.

COMPLETE ANALYTICS

Powerful real-time trending and analytical tools.

SERVICE DELIVERED

Available as either traditional OnPremise (licensed software) or OnDemand (cloud-based SaaS).

Product Overview

Watch this Video Overview of the AssurX Quality Management System Platform.

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Customer Testimonial

Listen to What Other Medical Device Manufacturing Professionals Have to Say About AssurX.

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Case Study

Learn How a Cardiac Device Manufacturer Was Able to Eliminate Over 2,400 Manual Hours Per Year Using AssurX.

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“The team at AssurX was fantastic throughout the design, implementation, and launch of our QMS system.”

Quality Management Built for Medical Device Regulatory Compliance

AssurX quality management system software is designed to support requirements and standards for the FDA and EU MDR regulated medical device manufacturing industry. The solutions seamlessly integrate, creating an ironclad closed-loop system to identify, track, resolve, document and report all quality and compliance issues across every part of operations—even into the supply chain.

Using AssurX’s closed-loop quality management and software, you know immediately when an issue arises at any point of origin. All relevant areas of your organization share the information needed to contain, evaluate and quickly resolve the problem.

Using powerful, real-time analytical tools the software helps companies identify, assess and remediate risk exposure; perform the detailed trend analysis needed to prevent quality and compliance problems and continually improve operations.

AssurX boasts mature compliance management capabilities with extensive audit trails, security controls, and electronic signature and records functionality that meets or exceeds rigorous standards regulatory requirements.

AssurX Quality Management System Software Features

CAPA Integration

Automatically track, trend, resolve and document all product issues—initiated from any source, across all functional areas—before they become costly problems. Reduce or prevent quality incidents. Control costs and make better products the first time around.

Compliance-Ready

Designed with flexibility to meet changing cGXP and FDA regulations, the software guides users step-by-step through the process to meet requirements. Preconfigured forms contain all pertinent information blocks required for compliance and smooth operations, dramatically reducing the risk of non-compliance. And, all records are easily accessible in one repository.

Business Intelligence

Enterprise-wide Intelligence with dashboards, KPIs and metrics. Get real-time trending with graphical dashboards and analytics that deliver instant business intelligence, accessed anywhere with an Internet connection.

Seamless eMDR

The FDA’s device reporting system offers huge potential savings in time and money—if it can be properly used. AssurX “feeds” the right information in the correct manner, for seamless FDA compatibility.

eSignatures

eSignatures, 21 CFR Part 11: AssurX’s solution is designed to meet or exceed this important regulation’s strict audit trail and e-data integrity requirements.

Guaranteed HIPAA

Make certain e-data is open only to those who are allowed to see it. AssurX makes it easy to “lock out” those who aren’t authorized to view any e-data field that requires shielding.

Risk-based Quality Management

Built-in risk assessment features for critical QMS processes such as CAPA and a robust Risk Management solution helps you prioritize activities and meet ISO standards for “risk-based thinking” in quality management systems.

Simple Integration

Integrate to ERP, MES, HR, SCM, internally developed applications, databases, etc., using a robust, flexible open interface.

One QMS Platform Delivers Every Solution for Medical Device Manufacturing

CAPA Management

Audit Trail, Electronic Signatures

Complaints Management

Audit Management

Manufacturing Quality Management

Electronic Medical Device Reporting (eMDR)

Pre-Configured Medwatch 3500A Process

Customer Quality

Supplier Quality Management (SQM)

FDA Compliance

Validation

“The system was deployed under budget and ahead of schedule.”

Corrective And Preventive Actions Management

The AssurX CAPA solution can effectively manage the resolution of any issue regardless of where it originates or how many departments the problem encompasses.

It is fully integrated with other quality-related processes such as audits, nonconformance, customer complaints, and change management. Issues initiated from any department are investigated, root causes identified, corrective and preventive actions planned and implemented across operations, and then they are evaluated for effectiveness.

Medical device companies can use the AssurX system to control costs and improve their products while meeting regulatory requirements for closed-loop quality management.

“For us the benefit of using AssurX is the audit trails, electronic signatures and workflow control. Before AssurX our processes didn’t move. AssurX enables us to know who is doing what, and when they need to have it done.”

– LiseAnn Bailey, Global Cardiac
Assist Device Manufacturer

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Compliant Audit Trail, Electronic Signatures

Built to ensure FDA compliance, the software incorporates audit trails and electronic signatures compliant to 21 CFR Part 11 and maintains an easy to access, secure time-stamped archive.

Audit trail of all MedWatch 3500 as submitted, as well as all follow-ups, modifications, and attachments
Query on all audit trails
View edits/changes in any form in the audit trail showing the before/after field values
View changes on entire record at once, not just individual fields
Electronic signatures cannot be modified, copied, transferred or deleted
Accommodates signature comments

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“To effectively and efficiently manage a significant volume of regulatory documentation…you need a reliable and highly configurable system to meet that challenge.”

Manufacturing Quality Management (NCMR, Deviations, Issue Tracking)

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. This closed-loop system is fully integrated with other quality and compliance processes and follows ISO and GMP standards for best practices. Track trends, cycle times and costs to facilitate root cause analysis and improve efficiency.

“With AssurX, we have significantly improved our efficiency and productivity.”

Angiotech

Change Management

A flexible, central system orchestrates, tracks and documents changes across all functional areas of a business. It creates a consistent, compliant closed-loop method to process any type of change (e.g. business process, product design, documentation, etc.). Proposed changes initiated from any department are evaluated; change plans are mapped out; tasks, reviews, and approvals assigned and tracked; then approved changes are released and implemented across operations; and training programs for new materials are initiated.

With easy, full integration to other quality related processes, it keeps coordinated control over changes across the organization.

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Document Management

The AssurX document management solution provides integrated, easy and effective management of controlled content throughout its life cycle—from change orders through release approval, dissemination and training. Get rapid, secure access to current and accurate documents at all times. AssurX Document Management allows businesses to improve global visibility of process changes, reduce risk and labor costs associated with use of erroneous and outdated procedures, and demonstrate regulatory compliance to inspectors.

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Regulatory Reporting

AssurX solutions follow industry standards and best practices for closed-loop quality systems for medical devices, pharmaceutical and other life science industries. The system guides the process of determining the reportability of every complaint using decision-tree processing, automating the evaluation of reporting requirements for the US FDA, Canada, European Union (EU MDR), and Australia. Automatically manage report due dates and notify assignees when reporting tasks become due or past due. Generate MedWatch 3500A and other vigilance reports in PDF format. Generate follow-up and supplemental reports based on changes to previously submitted reports.

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Electronic Medical Device Reporting (eMDR)

AssurX eMDR provides a closed-loop, end-to-end automated reporting system without the requirement of any additional third party tools or EDI systems. Everything is built-in, ready to go. MedWatch 3500A and other vigilance reports can be generated and submitted directly from the system. The solution delivers improved on-time reporting that also substantially improves accuracy and productivity in your reporting process.

Control of the entire MDR reporting cycle
Built-in dashboards with real-time tracking for all MDR submissions
Complete end-to-end solution—no need for 3rd party tools or components
Submit 5- & 30-day MedWatch reports, follow-up reports and attachments
Central management of tasks with notifications, escalations, rules and reminders
Support for US Med Device Baseline, EU Vigilance and Canadian Med Device Reports

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Pre-Configured MedWatch 3500A Process

The entire MedWatch 3500A process is pre-built and ready to use out of the box. Simply enter the medical device company’s manufacturing ID and general default values such as address information to get started. No additional configuration is needed—users can start using the process and submitting to the FDA. For medical devices companies, eMDR (electronic medical device reporting) is fully integrated, allowing MedWatch 3500A and other vigilance reports to be generated and submitted directly from the system.

“We chose AssurX for its ease of use, the ability to configure the system to our workflow, Zero Client architecture for quick deployment worldwide, ease of integration with ERP systems such as SAP, as well as for its advanced query functionality.”

Customer Quality Management

Improve customer satisfaction and retention by quickly resolving product quality issues reported by customers in a thorough, consistent and predictable manner. Quality issues from customer related sources are logged and investigated. Root causes identified, and corrective/preventive actions are launched across operations, and then checked for effectiveness. Includes management of complaints, issues arising from field service events, incoming calls, and product returns.

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“We felt AssurX’s ease of configurability allowed us to continue to adapt our processes and solutions to Genzyme’s increasing product portfolio, facilities and international markets.”

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FDA Compliance

AssurX boasts mature compliance management capabilities with extensive audit trails, security controls and electronic signature/records functionality that meet or exceeds rigorous regulatory requirements. The system is even flexible enough to keep you in compliance with changing cGXP requirements. AssurX’s preconfigured closed-loop solutions deliver efficient processes to manage complaints, supplier quality, document control, CAPA, change, and audits, etc., while a state of control and proof of compliance is maintained continuously, in a central, accessible system.

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Validation & Professional Services

AssurX offers an array of documentation, and pre-configured validation scripts and templates to assist in your implementation. IQ/OQ and process qualification procedures provide a starting point for alignment with your computer software master validation plan. To get your solution working fast and smoothly, AssurX’s regulated industry experts offer professional deployment services, mentoring programs, validation, integration services, tailored scripts, test plan assistance, go-live support, and process documentation, among many others.