Resources

WEBINARS ON DEMAND

QUALITY MANAGEMENT

Risk-Based Decision Making in QMS: Choosing the Right Tool for the Job

Selecting the right risk management tool — whether it’s FMEA, HACCP, Risk Registers, Bowtie Analysis, or others — is critical for effective decision making in QMS. This webcast explains several key risk management tools, their applications, and best-use scenarios.

Human Factors in CAPA: Enhancing engagement, accountability, and management commitment

Explore the powerful role human factors play in driving the success of your CAPA processes. Learn how leadership can champion a culture of quality, involve team members in meaningful ways, and ensure that CAPA becomes a collaborative effort that drives continuous improvement.

Elevating Manufacturing Excellence: Transformative Strategies for Quality Management Systems

In today’s competitive landscape, product quality is not just a reflection of brand integrity; it’s a cornerstone of customer loyalty and satisfaction. As industries evolve and customer expectations rise, the adoption of a robust Quality Management System (QMS) has shifted from a recommended best practice to a critical necessity.

5 Pillars of a Modern Enterprise Quality Management System

The modern enterprise quality management system (eQMS) has evolved to streamline the movement of quality processes and act as a single point of truth for compliance. It integrates activities and information seamlessly to manage, track and report, ensure product quality and facilitate all compliance with GxPs, FDA, HACCP, ISO standards and more.

A Proactive Approach to Inspection Readiness: Harnessing Automated EHS for Safety and Compliance

Combining employee safety and well-being with increased OSHA fines, there is a heightened need for proactive management of workplace Environmental, Health, and Safety (EHS) incidents. Developing a standardized, streamlined approach to EHS incident management is essential for protecting workers and avoiding compliance violations.

Prepare for a Successful Audit Using an Automated QMS

Do you feel confident that you have all the key quality processes in place to support an audit, either announced or unplanned, with your current quality management solution? Properly organizing your quality data to help drive business decisions ensures you stay current on trending issues and allows you to be proactive vs. reactive.

6 Elements of a Modern Change Management System

Change management in a QMS requires critical considerations that will make those changes sustainable and effective. When done right, modern change management creates a path to continual improvement that meets compliance requirements for FDA, ISO, internal quality control, customer requirements, and other regulatory bodies.

Document & Training Management Systems: The Backbone of a Modern QMS

Document control and training management processes are a logical starting point when integrating an electronic QMS. Standardizing procedures and other information in the document management system and engaging users with employee training establishes your quality expectations and creates awareness of the system.

ENERGY & UTILITIES

Managing (more than just) Compliance with TSA Pipeline Security Directives

TSA pipeline security guidance and directives require a range of plans, policies, and controls. Adhering to these requires collecting, monitoring, and acting upon a vast array of data related to IT and OT systems.

Automating Asset Change Management for NERC CIP-010 R1

Explore the functionality required for an effective Asset Change Management solution that enables compliance with CIP-010, and how the AssurX ECOS addresses those challenges.

Simplify NERC CIP Reporting Using Automation

Streamline efforts by standardizing the data requested and shares best practices for data and evidence mining, extracting data from the source and transposing it into the expected format for the ERT to improve the overall quality of cybersecurity programs.

Patch Management For NERC CIP Compliance: Turning Awareness Into Action

See first-hand how AssurX ECOS software centralizes and automates required processes and actions for evaluation, validation, and installation of public and private patching.

Implementing an Enterprise NERC Compliance Management System

AssurX and Tri-State Generation explain how they prepared for and deployed a consolidated system that automates ad-hoc evidence submissions, evidence reporting, corrective actions, and other compliance activities.

Simplifying NERC Compliance by Automating Reliability Standard Audit Worksheets (RSAWS)

This webinar demonstrates how utilizing a dynamic RSAW management system enables Registered Entities to be spot check and audit-ready with current NERC requirements.

Automating Document Management & Evidence Collection

Learn how automating document management & evidence collection ensures that your documents and evidence prove compliance with NERC standards. Concludes with a brief AssurX product demonstration.

Leveraging an Enterprise Software Platform for NERC and Regional Compliance

See how AssurX ECOS integrates solutions for meeting NERC and regional mandates with automated, connected, configurable workflow processes. Focus areas include documents and evidence, assessments, audits and RSAWs, issue mitigation, and internal controls.

Exploring the 3 Most Violated NERC CIP Standards

Failed audits can result in significant fines and costly remediation to bring systems back to a state of compliance. A proactive approach using industry best practices can significantly improve compliance and reduce threat risks to your infrastructure.

LIFE SCIENCES

Revolutionizing IMDRF Coding with AI

Post-market surveillance is crucial for medical device manufacturers. However, traditional complaint handling systems often use inefficient manual processes. These systems also rely on inconsistent methods and fragmented workflows. Consequently, compliance risks and patient safety are compromised. Additionally, brand reputation is put at stake. Discover how the 3Analytics solution effortlessly integrates with systems like AssurX’s QMS for compliance, efficiency, and safety monitoring. Explore real-world success stories, such as a client who improved operations significantly by reducing manual efforts and ensuring coding consistency.

EU MDR Preparedness: Implementing a MIR-Ready Complaint Management Solution

Postmarket surveillance and reporting under EU MDR will be exponentially more in-depth as it expands to focus on the entire life cycle of the product. The new EU Manufacturing Incident Report (MIR) v 7.2.1 requires extensive information, from market distribution data to clinical and detailed failure data, to cause investigation and conclusions. While much of the information submitted to EUDAMED will come from ancillary systems in the manufacturing chain, a significant portion of data will come directly from your quality management system (QMS).

Automating Complaint Management for Life Sciences: A Best Practice Approach OnDemand Webinar

Automating complaint management reduces potential risk to public safety and subsequent FDA action by expediting investigations and root cause analysis of safety and efficacy issues. Quality management software built on best practices eliminates disconnected processes and provides a centralized, controlled system to manage the complaint handling process until the investigation is satisfactorily closed and reported if necessary.

EU MDR Implementation and Organizational Change Management Webinar

As a consequence of the COVID-19 pandemic, the European Commission (EC) accepted a proposal to postpone the EU MDR application date. While the reprieve may be welcome by manufacturers who have delayed implementation or may still be working through their assessments, the extension should not delay the momentum towards full implementation.

One Platform. Every Solution.

Easily integrate all your quality management and regulatory compliance processes into a single quality software system with AssurX. AssurX provides all core quality and compliance processes within the software system. This removes 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.

Benefit from pre-configured workflows right from the start, ensuring a smooth transition to digital quality management. 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, enjoy the convenience of easily searchable data, allowing for quick retrieval and efficient information management, and saving valuable time. AssurX stands out as a user-friendly platform that allows for easy deployment, configuration, and integration with other software solutions.

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. Bid farewell to data silos and welcome a unified system for maximum 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