Resources

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AssurX Resource Center

GENERAL PRODUCT BROCHURES

ASSURX PRODUCT BROCHURE

Product overview, highlights and list of functionality and capabilities.

ASSURX CLOUD QMS

All about our Cloud QMS software delivery option.

ASSURX ECOS

Overview of the AssurX ECOS system for Energy & Utilities compliance.

SOLUTION DATASHEETS

BROCHURE

Product overview, highlights and list of functionality and capabilities.

BROCHURE

Product overview, highlights and lis of functionality and capabilities.

BROCHURE

Product overview, highlights and list of functionality and capabilities.

Assurx Analytics

Utilize real-time live data, so you are always analyzing the current data, rather than time-late warehoused information. 

Audit Management

Manage any type of audit activities, data, and processes while significantly reducing time and effort to support audit-readiness.

Calibration Management

Build confidence and trust in measurement reliability with calibration management solution.

Change Management

Orchestrate, track and document change across all functional areas of an organization.

Complaint Management

Manage postmarket adverse events and OOS while improving compliance, product safety and product innovation.

Corrective and Preventive Actions (CAPA)

Create a clear path to resolution and prevention through root cause analysis of nonconformances, system, or process failures.

Design Control

Ensures medical devices designed and manufactured meet specified compliance requirements and necessary design control phases are addressed.

Deviation ManagemenT

Efficiently find root cause and apply corrective actions to minimize the risk of problem recurrence.

Document Management

Automated document management and storage throughout the document lifespan.

EHS Incident Management

Elevate your quality and safety standards with systematic and detailed investigations.

ELECTRONIC MEDICAL DEVICE REPORTING (eMDR)

Overview of the AssurX automated electronic medical device reporting solution.

EU MIR SUBMISSION

AssurX electronic reporting solution automates the EU Manufacturer Incident Reporting (MIR).

Quality Management Review

Conduct through and standardized evaluations of QMS suitability and effectiveness.

PATCH COMPLIANCE MANAGEMENT

Patch Compliance Management helps manage critical infrastructure protection as part of a defense in depth strategy.

Risk Management

AssurX Risk Management software facilitates risk scoring, identification, assessment, remediation, and prevention.

Supplier Quality Management

Manage suppliers, vendors, contract manufacturers, and service providers with one solution to enforce your quality and compliance goals.

Training Management

Centralize and automate training management to enable a continuum of quality, compliance and accreditation activities.

VALIDATION BROCHURES

VALIDATION MANAGEMENT SERVICES

Making EQMS changes & validation easier for regulated organizations.

RISK-BASED VALIDATION SOLUTION

Customized validation services based on a critical thinking approach that supports the GAMP 5 Model.

AUTOVALIDATOR

The paperless AssurX AutoValidator integrates with the Validation Management Solution to automate test execution.

SERVICES

PROFESSIONAL SERVICES

Overview of Professional Services offerings and details about methodologies.

TRAINING SERVICES

Training catalog with options for virtual classroom, onsite and e-learning with course descriptions.

NERC UPDATE SERVICE

For energy/utilities: the easiest way to keep your system current with all new and revised NERC standards, PDFs & RSAWs.

WHITE PAPERS

BRIDGING THE QUALITY MANAGEMENT DIGITAL DIVIDE

High-performing manufacturers can bridge the gap in real-time, with immediate access to actionable insights from a QMS.

SYSTEM INTEGRATION WHITE PAPER

This System Integration white paper details and compares methods for enterprise quality system integration.

21 CFR PART 11 COMPLIANCE BULLETIN

This AssurX System Integration white paper details and compares methods for enterprise quality system integration.

DISPELLING COMMON MISCONCEPTIONS ABOUT SOFTWARE VALIDATION

This solution brief addresses common myths and misconceptions about computer system validation.

6 ELEMENTS OF A MODERN CHANGE MANAGEMENT SYSTEM

Learn the requirements for a Modern Change Management System.

GMP AUDITS: MOVING FROM ADVERSARIAL TO COOPERATIVE

Regulated companies need audits to establish both compliance and performance, which go hand in hand.

QUALITY MANAGEMENT SYSTEMS: ESSENTIAL STRATEGIES FOR SUCCESS AND PITFALLS TO AVOID

The importance of an automated enterprise quality management system (EQMS)

Stay Informed with Content from our Experts

AssurX: Quality & Compliance Systems for Every Enterprise

When you choose AssurX, you’re choosing decades of expertise in regulatory environments and innovation in quality management. Our unwavering focus on quality management means you’re getting a best-in-class solution.

You won’t be burdened with a scaled-down or inflexible quality management software solution. We’ve built the best solution to help you save time and maintain consistency.

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One Platform. Every Solution.

Seamlessly integrate all quality management and regulatory compliance management processes with one software system. AssurX provides all core quality and compliance processes within the software system. This eliminates the need to budget for and install individual quality “modules.” Pre-configured workflows are available to you from day one with our quality management software.

AssurX is an exceptional platform that facilitates transitioning from a labor-intensive, paper-based process to a streamlined electronic system. By adopting AssurX, you can embrace the enhanced organization that comes with digitizing documents and files.

With AssurX, everything is easily searchable, allowing for quick retrieval and efficient information management. This level of organization drastically improves accessibility to records, reducing the time wasted.

First, implement the solutions you need now, then seamlessly connect more as you are ready. No other quality management system is easier to deploy, configure, and modify. Integrations with other software solutions make AssurX invaluable. Your data won’t be stuck in several silos. Instead, you’ll have one unified system for optimal efficiency.

Audit Management

CAPA Management

Calibration Management

Change Management

Complaint Management

Customer Quality Management

Deviation Management

Document Management

EHS Incident Management

Nonconformance Management

Quality Management Review

Risk Management

Supplier Quality Management

Training Management

Validation Management Solution