Ensuring Rigorous Standards Across Every Operation
At Elemental Machines, we understand that maintaining GxP compliance with industry regulations is not just about adhering to rules — it’s about ensuring the quality and reliability of your scientific endeavors. Our compliant, LabOps-focused connectivity solutions integrate seamlessly with your lab or manufacturing operations to safeguard your progress, now and into the future.
For regulated teams, the validated core comes first. Advanced insights are opt-in and configurable to your SOPs.
Built on a Foundation of Regulatory Expertise
Our platform and services are carefully engineered to help you navigate the complex landscape of life sciences regulatory compliance, supporting GLP/GMP workflows with audit-ready records and controls:
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Global regulatory adherence
Our systems are designed to meet critical regulatory requirements, including GxP compliance, FDA, and ISO standards, with role-based access, time-stamped audit trails, and e-signature workflows.
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Streamlined audit readiness
With our solutions, you’re always audit-ready; we provide comprehensive documentation and support to simplify the compliance process, so investigations, CAPA linkage, and reports are fast and defensible.
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Risk mitigation
Proactively address potential compliance risks with our predictive tools and analytics, ensuring you stay ahead of issues before they impact your operations.
Enhancing QA/QC
Our compliant connectivity solutions extend beyond simple adherence, enhancing your quality assurance and quality control (QA/QC) processes with advanced tools designed to optimize accuracy, traceability, and audit-readiness:
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Integrated validation processes
From cold storage monitoring and device calibration to environmental monitoring and instrument integration, our platform centralizes vital data with validation support (IQ/OQ/PQ) and change-control guidance.
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Data integrity and security
We safeguard your data with role-based access, tamper-evident logs, and retention controls, ensuring the integrity and confidentiality of your critical information as it flows to your systems of record via our APIs, direct database connections, and custom reports.
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Customizable compliance frameworks
Tailor controls and features to match SOPs across R&D and GMP, enabling opt-in analytics where you need them.
“Quality is built into our products, our data, and our processes. That quality foundation is exactly what our customers demand in their own operations, and Elemental Machines’ platform is a critical component to prove that quality is adhered to in every respect, from the manufacturing environment to sample integrity to clean room specifications — our automated data solutions provide the foundation for your own GxP quality adherence standards.”
Kevin Ghiasi
VP of Global Alliances