GMP Software
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.
GMP Software 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.
Document Management System
Orcanos e-DMS is a document control system for medical devices. It enables users to create, search, approve, and archive product launch documentation. It supports all document types and improves quality processes while reducing time to market.
Risk Management
ISO 14971
Effective QMS requires good risk management practices in the medical device sector, following ISO 14971. Risk management should be applied throughout the product lifecycle, including research, development, and post-marketing observation to ensure quality and safety.
Change Management (ECO)
Orcanos ECO management system digitally controls ongoing change processes in the product lifecycle, including monitoring SOPs and design specs to enhance productivity.
Training Management
Streamline Your Employee Training with Orcanos' Training Management Software
CAPA Management
Achieve compliance and enhance your quality control processes with Orcanos CAPA management system.
Audit Management
Prepare and manage Audits electronically. Get alerts on Audit findings if overlooked.
Nonconformance
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!
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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