Resources
WEBINARS ON DEMAND
QUALITY MANAGEMENT
Strong supplier relationships don’t happen by accident; they’re built through intentional processes and the right mix of tools at each stage of the supplier lifecycle. During this webcast, we’ll walk through a practical, start-to-finish approach to Supplier Quality Management, showing you how to choose (and use!) the right tools for onboarding, monitoring, auditing, and continuous improvement.
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.
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.
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.
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.
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.
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 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
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.
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.
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.
See first-hand how AssurX ECOS software centralizes and automates required processes and actions for evaluation, validation, and installation of public and private patching.
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.
This webinar demonstrates how utilizing a dynamic RSAW management system enables Registered Entities to be spot check and audit-ready with current NERC requirements.
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.
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.
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
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.
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 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.
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.
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.
