GMP Compliance

Your Quality Management, Manufacturing, Risk and regulatory compliance in a single integrated system.

Ensure your business follows the U.S. FDA's current Good Manufacturing Practice (cGMP) standards. These guidelines assure consistent product manufacturing in a controlled environment, guided by quality standards. A suitable cGMP software system can simplify ongoing GMP (compliance.

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GMP Compliance solution that works for you

At Orcanos, we guarantee that your products are manufactured in accordance with Good Manufacturing Practice (GMP) and regulatory guidelines and standards. We offer a comprehensive quality management system to ensure that your products meet and exceed regulatory compliance standards like ISO 13485, 21 CFR Part 11, ISO 14971, and others. Orcanos is the sole software that merges design control, quality management, and regulatory compliance to 21 CFR Part 211 Subpart D - Manufacturing Equipment Management into a single integrated system.


The Orcanos nonconformance management software allows for easy recording and tracking of non-conformance issues, from initial identification to resolution. Additionally, Orcanos ensures that all laboratory controls and test procedures meet regulatory standards for your product components.

Take your regulatory compliance to the next level with Orcanos. Book a demo today and experience the power of our integrated solutions firsthand!

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Electronic Device History Record (DHR) System

The Orcanos e-DHR system includes the following capabilities: Secured electronic, and centralized web-based system; Tractability to other quality processes, such as Change Control, FMEA, Verification, Complaints, CAPA, etc; Verification and validation, and QA reports; Smart dashboards; Workflow and e-sign automation etc.

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