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“AssurX…allowed easy management of all CAPAs on a local level as well as knowledge exchange between management throughout the global organization.”

– Manager, Global Quality
Info Systems

bausch and lomb life sciences company selects assurx quality and compliance management

Enterprise Quality Management System Software for Life Sciences

Maintaining the highest quality levels and strict regulatory compliance affects the bottom line and can be a matter of life and death for medical device, biotechnology, and pharmaceutical manufacturers.

To protect both companies and consumers in meeting increasingly strict FDA and other regulatory body demands. It’s essential to understand and meet the challenges of global corrective and preventive action (CAPA), complaints management, change control, audit management, supplier quality, and overall product quality management.

In addition to the FDA’s stringent 21 CFR Part 11, 54, and 58 requirements, companies face severe regulatory scrutiny from the Department of HHS and its HIPAA patient privacy regulations. It is incumbent upon life science manufacturers to use the software, hardware, and system processes that ensure only those required to see a given piece of data can access it.

AssurX software is designed with enterprise quality management, cGXP, and life science-specific regulatory requirements in mind. Successful life science companies are using the AssurX QMS software platform to monitor, manage centrally, and improve their quality and regulatory compliance processes—and the bottom line—across all operations.

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Efficient, cost-effective enterprise quality management system designed to meet life science regulatory requirements.

Single Platform

One seamlessly connected solution to improve quality, ensure compliance, manage risk, and streamline workflow.

Compliance Built-in

Every solution is 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 QMS).

AssurX Quality Management System and Compliance Management Software Platform

Product Overview

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

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Customer Testimonial

Listen to What Other Life Science Manufacturing Professionals Have to Say About AssurX.

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Case Study

Learn How a Global Pharmaceutical Manufacturer Was Able to Eliminate Over 10,500 Personnel Hours Per Year Using AssurX.

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“We are a fast-growing company and our systems need to be ahead of our growth,”

TEDOR Pharma

Enterprise Quality Management Built for FDA Compliance

AssurX quality management software system is designed to support requirements and standards for FDA regulated industries. 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 software, you not only know immediately when an issue arises (from any source: customer, supplier, internal), all relevant areas of your organization share the information needed to contain, evaluate and quickly resolve the problem. By utilizing 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 of regulatory requirements.

Not only fully compliant with 21 CFR Part 11 and Part 820, but it is also flexible enough to keep you in compliance with changing cGXP requirements. AssurX’s preconfigured closed-loop solutions deliver fully FDA-compliant processes to manage complaints, supplier quality, document control, corrective and preventive action (CAPA), change control, audits, and more. In contrast, 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 preconfigured solution comes with a PQ based on industry best practices and the latest regulatory guidelines.

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AssurX QMS For Life Sciences 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 or dangerous problems. Reduce and prevent quality incidents. Control costs and make a better product the first time around.

Compliance-Ready

Designed to meet changing cGXP, HHS, and other 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.

Business Intelligence

Enterprise Intelligence With Dashboards, KPIs & Metrics: Get real-time trending and global oversight with graphical dashboards and analytics that deliver instant business intelligence, accessed anywhere with an Internet connection.

21 CFR Part 11 Compliant

Electronic Records; Electronic signatures, 21 CFR Part 11: AssurX’s solution is designed to meet or exceed strict regulations audit trail and e-data integrity requirements.

Enables HIPAA Compliance

Make certain e-data is open only to those who are allowed to see it. AssurX makes it easy to “lockout” 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 Life Science Solution

Audit Trail, Electronic Signatures

Complaints Management

Audit Management

Manufacturing Quality Management

Document Management

Training Management

Regulatory Reporting

Electronic Medical Device Reporting (eMDR)

Change Management

Validation

CAPA Management

Supplier Quality Management (SQM)

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

“AssurX’s zero-client architecture allows us to rapidly deploy our process and solution to new countries and partners without extensive software downloads or IT support.”

Sanofi-genzyme selects AssurX Quality Management System

Corrective And Preventive Actions Management

Automatically capture detailed data about quality problems from anywhere in operation with the streamlined AssurX CAPA solution. Get real-time trending of out-of-specification, out-of-trend, and other deviations.

Control costs and improve products while meeting regulatory requirements for closed-loop quality management with electronic records and signatures and time-stamped audit trails. Because it’s fully integrated with other quality-related processes such as audits, nonconformance, complaints, etc., no matter where an issue originates or how many departments the problem touches, the system can effectively manage its resolution.

“We integrated several solutions into our system. Deviations, CAPA, complaints, disposal management and laboratory incidents. People adapted very quickly and very easily to the software. It was a phenomenal on-boarding experience for us. We have the system in 8 different countries in 5 languages.”

Servier Life Sciences Company selects AssurX QMS

Audit Trail, Electronic Signatures

Every AssurX solution comes fully compliant with 21 CFR Part 11. Once added to a specific record, signatures cannot be modified, copied, transferred, or deleted. Signatures can be of various types (approval, acknowledgment, etc.) and may include comments with each. AssurX automatically maintains a secure, time-stamped compliant record archive (audit trail) of all electronic records changes. Records and changes are displayed together in their entirety.

  • Query on every audit trail
  • Audit trail on file attachment modifications
  • View edit changes on forms in the audit trail showing the before/after field values
  • Manage proxy signatures allowing user to designate backup approvers

Download the Complaint Management Solution Datasheet

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Complaints Management

The AssurX Complaints Management and Regulatory Reporting system provide a best practices process for managing the entire event lifecycle from event intake through investigation, root cause analysis, and reporting to regulatory agencies. It features proven best practice matrixes, management dashboards, and robust audit trail reports and controls.

Download the Audit Management Solution Datasheet

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Audit Management

AssurX’s solution delivers a comprehensive audit management process that adheres to current 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 personnel. After follow-up actions are addressed, a final report is issued and routed for complete closure.

“We’re tracking CAPA activity, internal audits, supplier corrective actions, OOS, plus many other processes.”

abbott vascular logo

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. 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.

Download the Supplier Quality Datasheet

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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 and correct them before they become significant issues.

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

Angiotech Life Sciences Company selects AssurX Quality Management

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 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 are 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 the organization’s changes.

Download the Document Management Solution Datasheet

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Document Management

AssurX’s 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 the use of erroneous and outdated procedures, and demonstrate regulatory compliance to inspectors.

Download the Training Management Datasheet

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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 is always effectively trained for the job, all training is documented correctly, and training histories are accessible, auditable, and correctly reported when necessary.

Download the Life Science
Complaints Management and
Regulatory Reporting Brochure

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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 every complaint’s reportability 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

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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.

“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.”

Sanofi-genzyme selects AssurX Quality Management System

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 (PQ) procedures provide a starting point for alignment with your computer software master validation plan. We get your solution working fast and smoothly with AssurX’s regulated industry experts. Who offer professional deployment services, mentoring programs, validation, integration services, tailored scripts, test plan assistance, go-live support, and process documentation, among many others.

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