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.

Audit Management

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

Calibration Management

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

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.

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

Overview of the AssurX automated electronic medical device reporting solution.

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

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

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

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)

AssurX: Quality & Compliance Systems for Every Enterprise

When you choose AssurX, you’re choosing more than two decades of expertise in regulated environments and continuous innovation in quality management. Our unwavering focus on quality management means you’re getting a best-of-class solution, not a scaled down or inflexible software solution.

One Platform. Every Solution.

Seamlessly integrate all quality and compliance processes with one software system. Start by using just the solutions you need now, then easily add more as you are ready. No other system is easier to deploy, configure, and modify.

CAPA Management

Training Management

Validation Management Solution

Document Management

Supplier Quality Management

Customer Quality Management

Complaint Management

Change Management

Risk Management

Audit Management

Quality Management Review

Deviation Management

EHS Incident Management

Calibration Management