“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.”

genzymeLogoMobile

Quality Management + Compliance for Medical Device Manufacturing

Maintaining the highest quality levels, and a strict state of control and regulatory compliance not only affects the bottom line, it can literally be matters of life and death for medical device manufacturers. In addition to the FDA’s stringent device regulation requirements, medical device manufacturing companies also face serious regulatory scrutiny from the Department of HHS and its HIPAA patient privacy regulations. It is incumbent upon medical device manufacturers to use software, hardware, and system processes that ensure only those personnel required to see a given piece of data are in fact allowed to access it. AssurX software is designed with global quality management and medical device regulatory requirements in mind. Successful companies use AssurX’s, seamlessly integrated software to centrally monitor, manage and improve their quality and regulatory compliance related processes across all operations.

The AssurX Platform provides an end-to-end, flexible system for managing quality and regulatory compliance including FDA requirements for:

  • Establishment registration – 21 CFR Part 807
  • Medical device listing – 21 CFR Part 807
  • Premarket Notification 510(k) – 21 CFR Part 807 Subpart E
  • Premarket Approval (PMA) – 21 CFR Part 814
  • Investigational Device Exemption (IDE) – 21 CFR Part 812
  • Quality System (QS) Regulation/Good Manufacturing Practices (GMP) – 21 CFR Part 820
  • Labeling requirements – 21 CFR Part 801
  • Medical Device Reporting (MDR) – 21 CFR Part 803

In addition, Assurx software provides pre-configured solutions that create closed-loop solutions deliver fully FDA-compliant processes to manage complaints, supplier quality, document control, CAPA, change, audits, and and training.  A state of control and proof of compliance is maintained continuously in one central, securely accessible system. The AssurX software is validated and comes with IQ/OQ validation templates. Each pre-configured solution comes with a PQ based on industry best practices and the latest regulatory guidelines.

Enterprise-Wide Quality Management Made for Medical Device Compliance

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).

life-sciences-quality-management-system-infographic

“Companies such as 3M expect a field-proven solution, and AssurX delivers not only the product, but a high level of expertise.”

3m-science-newbranding-logo

Quality Management Built for Medical Device Regulatory Compliance

AssurX quality management system software is designed to support requirements and standards for the FDA 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.

FEATURES

AssurX delivers central control and improved compliance and business performance.

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

The AssurX platform offers an easy-to-use, flexible, integrated system of quality management solutions that are designed for FDA-regulated companies. 

“Companies such as ours expect a CAPA system that delivers, and demand expertise from a software company who has spent years in FDA-regulated industries.”

Thermo-Fisher-Scientific-logo-svg

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

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

Download the Complaint Management Solution Datasheet

Complaints Management

The AssurX complaints management and regulatory reporting system provide the ‘best practice’ approach for managing the entire lifecycle from event intake through investigation, root cause analysis and reporting to regulatory agencies. It features include best practice matrixes, management dashboards, and strong audit trail reports and controls.

Download the Audit Management Solution Datasheet

Audit Management

The AssurX audit management solution delivers a comprehensive audit management process and adheres to best practices for closed-loop findings, closure, task assignments, and escalation. Audits are conducted after being planned, findings are classified, and follow-up is assigned to the right area managers. After follow-up actions are addressed, a final report is issued and routed for complete closure.

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

KEYSTONEDENTAL-logo

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.

Download the Document Management Solution Datasheet

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.

Download the Training Management Datasheet

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, auditable and correctly reported when necessary.

Download the Medical Device Complaints Management and Regulatory Reporting Brochure

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, Europe, 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.

Download the Electronic Medical Device Reporting Datasheet

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

Download the Electronic Medical Device Reporting Datasheet

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.”

Abbott-medical-optics-logo

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.

Download the Supplier Quality Management Solution Datasheet

Supplier Quality Management (SQM)

AssurX’s SQM solution offers instant collaboration and visibility across your supplier network to vastly improve product quality. No matter the number or location of your suppliers and contract manufacturers, SQM lets you quickly detect, inspect, track, trend and contain supplier related quality issues quickly and correct them before they become bigger issues.

“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.”

genzymeLogoMobile

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.

“AssurX listens to you, takes the time to understand your business, and proposes pragmatic and relevant solutions.”

Galderma

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.

AssurX OnDemand Solutions

Learn How AssurX Works

Explore Case Studies

Request a Live Demo

Summary
software image
Author Rating
1star1star1star1star1star
Aggregate Rating
no rating based on 0 votes
Software Name
Assurx - Quality and Regulatory Compliance Solution
Operating System
Windows, MacOSx, Linux
Software Category
Business,Medical Device Manufacturing