eQCM: The All-In-One Digital Quality Management System
eQCM, formerly Xybion QMS, is a cloud-based solution for ensuring organizational compliance with diverse regulatory requirements spanning production, data safeguarding, reporting, governance regulations, and more. eQCM offers a centralized platform that is easily configurable to organizational needs, with out-of-the-box functionality for fast deployment and enduring value.
What is eQCM?
eQCM is a comprehensive quality management software solution for organizations within highly regulated industries to manage their compliance and quality process flows. This platform helps researchers align with major regulatory requirements, featuring dedicated modules that support Corrective and Preventive Actions (CAPAs), audit management, change management, document management, IT governance, quality management, and more.
Constantly evolving regulations increase risks for organizations with high compliance demands, particularly those operating across multiple jurisdictions. A lack of standardized internal documentation procedures and fragmented processes significantly increases risk and creates vulnerabilities that can lead to errors, inefficiencies, and regulatory penalties.
eQCM overcomes compliance challenges by providing solutions that are compatible with global regulations, adaptable to business needs, and designed to safeguard quality processes. eQCM enables customization of processes to support unique workflows while maintaining compliance and efficiency, and integrates with existing systems and practices where possible.
Key Benefits of eQCM
Seamless Collaboration & Efficiency
A centralized system for quality management enables teams to collaborate more efficiently, eliminating disconnected systems and reducing silos across the organization.
Improved Scalability
eQCM is fully adaptable to the needs of specific teams, who can selectively deploy the modules they need without disrupting established workflows or adding unnecessary complexity.
High Data Integrity
Automated processes minimize data entry errors, improve efficiency in data collection and reporting, and free staff from tedious tasks.
Broad Compliance Support
eQCM provides dedicated modules for broad coverage of essential compliance processes, while supporting alignment with ISO, GxP, and 21 CFR Part 11 standards.
Rapid Implementation & Flexibility
eQCM modules support rapid deployment with built-in configuration tools to help companies overcome the last-mile problem with ease.
Core Modules
eQCM comprises a suite of robust modules designed to simplify compliance, streamline processes, and strengthen quality management across your organization, including:
CAPA Management
Simplify CAPA management with an integrated workflow that reduces complexity and connects seamlessly with core quality processes, or functions independently as a stand-alone module.
Audit Management
Streamline audits with comprehensive tools to measure, improve, and ensure quality across value chains, reduce risks and maintain customer satisfaction.
Change Management
Drive regulatory compliance and governance by standardizing change requests, risk assessments, and approvals throughout the entire change cycle.
Document Management
Utilize a robust system that adapts to your processes, providing configurable tools to holistically manage compliance data across your entire organization.
Internal Controls
Centralize risk assessment, monitoring, and control activities within one platform to ensure compliance with organizational objectives.
Incident Management
Improve response efficiency with secure, cloud-based tools that streamline collaboration, ensure compliance, and minimize incident risk.
IT Governance
Enhance compliance with full control of IT processes, minimizing risk while ensuring secure, efficient operations in both cloud and on-premise environments.
Nonconformances
Allows you to effectively automate and manage the nonconformance process in compliance with regulatory guidelines, providing management of nonconformances through automated, web-based tools for handling materials, methods, components, and products.
Complaint Management
To efficiently document, manage, and control customer complaints in compliance with current regulatory guidelines and best practices.
Competency Management
Implement a best practice approach to competency management to boost productivity, ensure compliance, and reduce costly errors through effective training, thereby strengthening skills and enhancing employee retention.
Programs and Objectives
You can set measurable goals, track performance, and link objectives to programs such as environmental, health & safety, and quality—ensuring compliance and alignment across the organization.
Quality Management
Unify quality operations in one platform to boost efficiency while giving your business the flexibility to scale toward long-term goals.
Why Choose eQCM?
eQCM is a unified out-of-the-box solution for managing quality and compliance processes across entire organizations. Robust configurability and simple implementation enable organizations to avoid the high costs associated with complex customizations and heavy IT demands. eQCM includes built-in capabilities to support compliance with diverse standards and requirements, including ISO, GxP, 21 CFR Part 11, IACUC, and AAALAC. These comprehensive offerings reduce fragmentation and siloing within organizations, ensuring process fidelity, data integrity, and strong chain of custody even for large, global organizations.
Digitization improves record-keeping, while the multilingual, cloud-based platform enables stronger collaboration between internal and external teams. With eQCM, teams begin realizing benefits quickly with rapid deployment and out-of-the-box functionality. eQCM can also be deployed within existing systems, meaning researchers and collaborators don’t need to overhaul their current workflows to stay compliant.
Customer Success Stories
A global pharmaceutical company sought to modernize its internal processes and integrate a robust eQCM solution within its global R&D operations. The change was driven by challenges with their previous paper-based, siloed system, which complicated audit preparation. Furthermore, their quality processes were fragmented across three sites in the U.S. and Europe, creating process gaps and further audit difficulties.
The Outcome
The company chose Instem’s eQCM, a robust, user-friendly, web-based platform, to solve its ongoing issues. The solution streamlined their quality management by eliminating disconnected systems, deploying only necessary functions, and automating processes to reduce errors, while ensuring 21 CFR Part 11 compliance. These changes strengthened internal compliance processes and boosted efficiency across all sites, ensuring the company was better prepared for audits and ongoing regulatory requirements.
How It Works
eQCM supports the entire quality journey with a diverse set of modules that ensure compliance and efficiency.
Configure
Rapidly tailor modules and workflows with the configuration engine to match your organization’s processes.
Document
Centralize and manage compliance-critical documents with full version control and audit trails.
Capture Events
Record incidents, non-conformances, and complaints in real time for immediate visibility.
Assess & Plan
Conduct risk assessments, implement CAPAs, and define change management action plans.
Execute
Automate tasks, notifications, and approvals to keep processes consistent and efficient.
Monitor
Track compliance, audit performance, and quality metrics through dashboards and reports.
Collaborate
Enable secure communication and coordination across teams, partners, and regulators.
Frequently Asked Questions
What types of processes does eQCM support?
eQCM supports CAPA, audits, incidents, documentation, change management, internal controls, IT governance, and more, helping you manage all quality processes in one platform.
How is eQCM deployed?
eQCM is available as a cloud-based solution, supporting collaboration across different sites.
Does eQCM integrate with existing systems?
Yes. It integrates with common enterprise and lab systems, ensuring seamless data flow and connected workflows across your organization.
What support and training are provided?
Instem offers onboarding, user training, and ongoing support to ensure smooth adoption and long-term success.
Get a Free Demo Today
eQCM helps to eliminate fragmented systems and provides the flexibility needed to adapt workflows, scale with business growth, and stay audit-ready at all times. Ensure compliance across your organization with robust modules that support diverse quality processes while improving efficiency and collaboration. Experience how eQCM can transform your quality management processes with a demo designed for your specific business needs.