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.
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
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.
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.
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.
Seamlessly integrate all quality and compliance management 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.