Orcanos QMS delivers a comprehensive cloud-based quality management system that guarantees your products surpass regulatory compliance standards, including ISO 13485, 21 CFR Part 820, and supports GMP.
Orcanos QMS provides a centralized platform to control all quality processes. This eliminates the need for a paper-based quality system and enables organizations to comply with strict FDA regulations and established ISO quality standards.
Automate your compliance processes and reduce the bottlenecks on document routing and sign-off. Fire training tasks and use Orcanos Change Control to release new revisions.
Integrating risk management into your QMS processes streamlines compliance with ISO 14971 and reduces risk throughout the device lifecycle.
Automate change management workflow and release a set of documents in a single batch.
Full Complaints Handling system, configure your workflow, leading you from investigation to resolution.
Achieve compliance and enhance your quality control processes with Orcanos CAPA management.
Get better prepared for your next audit or inspection.
Orcanos' nonconformance management simplifies the recording and tracking of non-conformance issues, from identification to resolution.
Streamline Your Employee Training with Orcanos' Training Management Software.
Consolidate all relevant documents, specifications, supplier schedules, scorecards, quality events, and risk assessments into a single, streamlined QMS.
Integrate Design Control (ALM) with Quality Management System and regulation to establish a centralized repository.
Effortlessly generate submission-ready documents (in Word or Excel) that conform to your company's templates.
Integrating risk management into the development process and quality events helps prevent potential hazards and failures while following ISO 14971 guidelines.
Orcanos supports electronic records and electronic signatures in compliance with 21 CFR Part 11/Annex 11.
Keep track of projects and the status of quality procedures with detailed reports and charts through our customized dashboards.
Our platform offers powerful customization tools to tailor your quality forms, e-sign processes, status flows, mandatory rules, and permissions to your specific needs and your company's Standard Operating Procedures.