GENERAL PRODUCT BROCHURES
Quality Management Software product overview, highlights and list of functionality and capabilities.
Learn more about our Cloud QMS option.
Overview of the AssurX ECOS Energy & Utility Compliance Software.
SOLUTION DATASHEETS
Utilize real-time live data, so you are always analyzing the current data, rather than time-late warehoused information.
Manage any type of audit activities, data, and processes while significantly reducing time and effort to support audit-readiness.
Build confidence and trust in measurement reliability with calibration management solution.
Orchestrate, track and document change across all functional areas of an organization.
Manage postmarket adverse events and OOS while improving compliance, product safety and product innovation.
Create a clear path to resolution and prevention through root cause analysis of nonconformances, system, or process failures.
Ensures medical devices designed and manufactured meet specified compliance requirements and necessary design control phases are addressed.
Efficiently find root cause and apply corrective actions to minimize the risk of problem recurrence.
Automate document management and storage throughout the document lifespan while also utilizing collaboration.
Enable effective management of all incidents while being able to identify opportunities to minimize or remove the associated root cause and risks.
Automated electronic medical device reporting (EMDR) solution for medical device manufacturers.
AssurX electronic reporting solution automates the EU Manufacturer Incident Reporting (MIR).
An automated process for conducting QMRs and managing the changes that may result from audit findings.
Patch process automation software solution helps manage critical infrastructure protection as part of a defense in-depth strategy.
AssurX Risk Management software facilitates risk scoring, identification, assessment, remediation, and prevention.
Manage suppliers, vendors, contract manufacturers, and service providers with one solution to enforce your quality and compliance goals.
Centralize and automate training management to enable a continuum of quality, compliance and accreditation activities.
VALIDATION BROCHURES
Leverage our expert team to streamline validation, minimize downtime, and reduce time-to-production.
Risk-based validation solutions with CSA and GAMP5 alignment.
A powerful automation tool designed to simplify and enhance your software validation process.
SERVICES BROCHURES
Overview of Professional Services offerings and details about methodologies.
Leverage our expert team to streamline validation, minimize downtime, and reduce time-to-production.
Training catalog with options for virtual classroom, onsite and e-learning with course descriptions.
For energy/utilities: the easiest way to keep your system current with all new and revised NERC standards, PDFs & RSAWs.
WHITE PAPERS
NERC AUDIT SURVIVAL GUIDE: TURN COMPLIANCE CHAOS INTO CONFIDENCE
The NERC Audit Survival Guide teaches you how top-performing utilities and energy organizations transform audit panic into a structured, repeatable, and even empowering process.
RISK-BASED VALIDATION: ALIGNING WITH FDA CSA GUIDANCE AND GAMP5
Traditional CSV (Computer System Validation) methods are giving way to smarter, risk-based approaches that emphasize critical thinking, streamlined documentation, and alignment with actual system use.
HOW TO RESPOND TO FDA FORM 483 AND AVOID A WARNING LETTER
Receiving an FDA Warning Letter can have devastating consequences, including the negative impact on the company’s regulatory standing, operations, revenue and brand reputation.
VALIDATING QUALITY MANAGEMENT SYSTEMS: BEST PRACTICES FOR COMPLIANCE SUCCESS
Neglecting compliance can result in costly delays, recalls, or unfavorable audit outcomes, potentially damaging your business’s reputation and bottom line.
HOW TO SAFEGUARD YOUR CAPA PROCESS FROM STAKEHOLDER FAILURES
Where CAPA programs often fail are in stakeholder engagement and accountability.
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.
Stay Informed with Content from our Experts
Compliance Says 35 Days. Threat Actors Need Less Than 5.
Electric utilities have spent years investing in cybersecurity programs, tooling, and compliance fr [...]
Navigating the Storm: How Utilities Can Master Regulatory Uncertainty Through Automation
In today’s energy sector, regulatory complexity is not a temporary headache—it is the new normal. U [...]
Why Life Sciences Companies Choose CDMOs with a Digital QMS
When I worked as a supplier quality team lead, I spent a lot of time auditing suppliers. Almost fro [...]
Improving the Supplier Corrective Action Request Process with the QMS
When I first started developing supplier quality management programs in pharma manufacturing, tracki [...]
AssurX: Quality & Compliance Systems for Every Enterprise
The quality and compliance journey can be an obstacle course of changing regulations and standards in a dynamic global market. The AssurX enterprise quality management system (EQMS) and the AssurX Energy Compliance System (ECOS) help guide organizations through the complexities of any regulatory landscape.
Our dynamic, connected quality and compliance management solutions help guide your journey by automating processes to streamline event management, minimize risk, measure performance and facilitate change. The result is a proactive system that improves efficiency, compliance readiness, product quality, and customer satisfaction.
One Platform. Every Solution.
AssurX centralizes quality management and regulatory compliance processes within a single, configurable software platform. The system includes core quality and compliance workflows out of the box, eliminating the need for separate modules and reducing reliance on paper-based or disconnected systems.
Organizations can deploy the solutions they need today and add additional capabilities as requirements evolve. With pre-configured workflows, searchable data, and flexible integration options, AssurX supports efficient deployment, configuration, and long-term scalability across the enterprise.
