In life sciences, compliance is nonnegotiable, and precision and reliability are mandatory. As the ever-expanding world of IoT and AI continues to grow at a breakneck pace, Elemental Machines is redefining connectivity with an unflinching focus on compliance. With our watchful eye, we monitor your ecosystem around the clock, ensuring uninterruptible integrity and steadfast efficiency of your operations — all while keeping your regulatory and compliance needs in check.
Regulatory Peace of Mind
It’s no secret: change is fast and frequent in this industry. Regulatory requirements evolve in response to societal expectations, scientific insights, and technological advancements. The growing impact of AI and the expanded role of data science have sped things up even more, spurring new regulatory frameworks. Keeping up takes more than just groundbreaking technology — it also requires a human touch.
At Elemental Machines, compliance isn’t just a feature of our platform — it’s the foundation. Our team is always regulatory ready, equipped with the expertise and tools to guide clients through consistent change. From data integrity and security solutions to quality-insurance sensors, equipment calibration to validation, we put your entire operation on a path to optimization. And with predictive analytics, our platform transforms your most complex data inputs into easily digestible insights, allowing you to anticipate and address issues before they arise.
Why are we so committed to compliance? Because we believe intelligent operations are the key to accelerated scientific discovery, enriched global health, and enhanced quality of life for all. We’re not just hardware and software experts; we’re purveyors of the peace of mind that comes with knowing your operations are supported every step of the way.
Adherence Made Manageable
Every move we make is driven by three principles: simple, intelligent, confident. We believe maintaining compliance isn’t just about following the rules. It’s about ensuring quality and reliability and doing it all in a way our clients can understand, manage, and maintain.
Our compliant connectivity solutions integrate seamlessly with your lab or manufacturing operations to safeguard your processes and progress. We design systems to meet critical regulatory requirements, including GxP, FDA, and ISO standards. And we provide comprehensive documentation and support to enhance your audit readiness and simplify the compliance process, making it easier to demonstrate adherence.
Proactive Risk Management
We don’t just react to compliance challenges — we prevent them with predictive tools and data-driven analytics. And our dedication to quality assurance (QA) and quality control (QC) isn’t just what we do, it’s who we are. Elemental Machines’ customizable solutions and services not only meet but exceed industry standards for precision, reliability, and compliance:
- Data integrity and security: We safeguard your data with robust, compliant security measures, ensuring the integrity and confidentiality of your critical information as it flows to your systems of record via our APIs and the largest integrations library in the industry
- Comprehensive documentation: We understand the importance of transparency and accountability in QA/QC. Our comprehensive suite of documents are a testament to our commitment to maintaining the highest standards of quality in our products and services. View our extensive list of documentation here: Core Management Document List
- Optimization tools: We leverage a unique suite of IoT-enabled sensors, innovative asset-tracking software, usage reports, cold-storage monitoring, and first-in-class data monitoring that protect your systems and provide actionable insights that optimize complex operations
- Calibration and training: Field calibration ensures your equipment continuously meets regulatory requirements. Our strategic partnership with industry-leader MicroPrecision sets industry standards for precision and reliability. And enhanced training materials help your team understand and implement the necessary compliance measures effectively
- Global reach: A worldwide network of ISO 17025 accredited labs ensures your sensors are NIST traceable and meet the highest calibration standards
- IQ/OQ protocols: We provide comprehensive installation qualification (IQ) and operational qualification (OQ) protocols, which ensure that all equipment is installed and functions according to stringent industry standards
- NIST-certified sensors: Our sensors are certified by the National Institute of Standards and Technology (NIST), offering precise measurements critical for regulatory compliance and quality assurance
- Integrated validation processes: From equipment calibration to validation of analytical methods, our connectivity solutions are designed to support GxP compliance and integrate seamlessly to ensure reliability
Navigating Regulatory Complexity
Our solutions are designed to keep you up to speed with evolving regulatory requirements and help you stay aligned with the strictest standards:
- GxP compliance: Our systems facilitate adherence to all GxP compliance guidelines including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP), equipping labs and manufacturing facilities with NIST-traceable sensors and comprehensive audit reports
- 21 CFR Part 11 compliance: We ensure the integrity of electronic records with encrypted data transmission, redundant storage, and robust user authentication
- ISO 17025 and ISO 9001:2015 certifications: We are proud to be ISO 9001:2015 certified, demonstrating our unwavering commitment to quality. Additionally, our operations adhere to ISO 17025 standards, ensuring the reliability and accuracy of our calibration processes. These certifications underscore our dedication to providing high-quality solutions that support rigorous regulatory requirements
Transforming Compliance Into Strategic Advantage
Elemental Machines’ design solutions transforms regulatory compliance into strategic advantages. By integrating IoT connectivity, you not only streamline compliance processes, you also produce a trove of data that drive organizational decision-making, inform purchasing decisions, enhance quality control, propel optimization, and more. With these newly discovered efficiencies, your organization can eliminate paper records, reduce silos, and gain insights by connecting your entire lab or manufacturing facility.
Ready to simplify regulatory compliance with certified connectivity solutions? Contact us today to learn how