Simplifying Adherence to Industry Standards
We understand the importance of life sciences regulatory compliance. Our compliance-supporting IoT connectivity solutions are designed to help you navigate the complex landscape of regulations with elevated ease, ensuring your equipment and processes align with the strictest standards.
Key Regulatory Frameworks and Standards
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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); we equip labs and manufacturing facilities with NIST-traceable sensors, field calibration capabilities, and comprehensive audit reports to instill best practices seamlessly.
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21 CFR Part 11 compliance
Elemental Machines is committed to upholding the integrity and confidentiality of electronic records; our platform ensures full compliance with 21 CFR Part 11, featuring encrypted data transmission, redundant data storage, precise time-stamping, and rigorous user authentication protocols.
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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.
Commitment to Quality and Compliance
Elemental Machines’ solutions are designed to transform regulatory compliance into a strategic advantage. By integrating our compliant IoT connectivity solutions, you not only streamline compliance processes but also unlock valuable insights that drive decision-making across your organization.
Our API capabilities allow seamless integration with existing Quality Management Systems (QMS), enabling you to draw meaningful correlations between environmental data, process yields, and quality outcomes. This integration supports comprehensive compliance and enhances overall operational intelligence.
