Adaptive QMS

Our QMS brings all the standard capabilities every QMS has, but it is 100% adaptive. In other words, you can choose to follow the industry’s best practices Orcanos provides or take it your own way and save time on onboarding by defining your own workflows and processes.

Compliance Management Features

Document Control

All company stakeholders, whether that is Research and Development, Quality Assurance, Clinical, or executive management, should have minimal barriers to effective Document Control.Orcanos combines all elements into a one-stop shop for documents via an integrated Design Control process and a Quality Management System, so you can easily reduce the bottlenecks on document routing and sign-off. This single repository gives end users digital access to approved or current documents, batch release documents via the Change Control, and automates the read & understand using the Orcanos Training Module.

Features
  • Record, approve, release, and archive documents efficiently
  • Automate document revision control, save approved documents to PDF, create a cover page, and archive outdated documents automatically.
  • Automate document approvals, signatures, release, and distribution to the relevant stakeholders, notify each stakeholder of changes and updates relevant to him; Customized workflow automation
  • Direct cost savings in physical space, paper, retention, and logistics.
  • Efficient electronic change control process to manage and track changes and change impact.
  • Manage Document security such as view/update permissions.
  • Real-time alerts and notifications
  • Personalized dashboards and analytics.
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Quality Events

Nonconformance Management

Tracking makes life easier.

When a product, service, or process fails and results don't match the requirements and specifications, deviations and non-conformance arise, and it is necessary to resolve it as fast as possible.Orcanos accelerates nonconformance management and reduces the overall cost by enabling record and tracking nonconformance from initiation to resolution and connecting it to the non-conformance source, such as complaints, which is also managed in Orcanos.

ECO - Change Management

Tracking makes life easier.

Orcanos enables organizations to create a proper workflow to control changes. Specifically, companies operating in an ISO-certified industry or environment must have effective engineering change control processes to guarantee product quality and safety.Our Engineering Change Order tool will digitally document and manage ongoing change processes within the product lifecycle. Documents related to Standard Operating Procedures, product design specifications, drawings, part inventory, and compliance forms - can all be tracked from the approval to the execution stage, enabling a batch release of artifacts and documents, automating action items, and training after release. . .

Features
  • Compliant with FDA CFR Part 820.
  • Automate change management workflow according to organization procedures.
  • Manage action items with real-time alerts and get notified when action items are due
  • Use Orcanos integrated system to view changes that were driven by a quality event, like a CAPA, Audit, or design change, up to the action items, and automated training tasks status.
  • Orcanos alerts and notifications ensure that all stakeholders are up to date with changes.
Compliance Management Features
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Compliance Management Features

CAPA Management

Be proactive—all the time.

By using CAPA (Corrective And Preventive Actions), you can address the root causes and take preventive and corrective actions as needed. By automating the entire CAPA process, from initiation to investigation and closure, Orcanos ensures compliance with regulations.
Orcanos CAPA tools enable the identification of risks and problems faster and more effectively by using one repository for ALM and QMS and through linking artifacts. It provides better impact analysis and tracking, and it is fully customizable.

Features
  • 21 CFR Part 11 compliant
  • Smart dashboards to track CAPAs that are due and overall view of open
  • CAPA status
  • Flexible workflow and e-sign automation based on organization procedures
  • Mange action items with real-time alerts and get notified when action items are outstanding
  • Use Orcanos integrated system to view changes that were driven by a CAPA, and CAPA driven by another quality event such as an Audit, up to the action items
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Training

Turn information into knowledge.

With rapid changes everywhere, you need to keep your organization up-to-date regarding regulations, standards, procedures, requirements, and any changes to compliance processes.Orcanos provides training solutions that keep everyone up-to-date with the relevant information, providing dashboards, customized workflows, and alerts to prevent potential human errors and remain complaints.

Features
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Compliance Management Features
Compliance Management Features

Manufacturing

Supplier Qualification Management

Be sure your vendors are qualified.

The Orcanos Supplier Qualification module directs all related documents, specifications, scheduled suppliers, scorecards, risk, quality events, and audits into one integrated quality management system.

Calibration Tools

calibration is essential for the safety products, in time.

Calibration of equipment is essential for compliance management. It provides safety validation and requires planning and meeting several standards. Orcanos offers direct access to the QMS tools to plan and execute calibrations, whether in-house or external.

Quality
Perspective

Orcanos Quality Perspective

you get better compliance management with the up-to-date regulatory-wise tools in a holistic environment.

R&D
Perspective

Orcanos R and D Perspective

when your compliance officer is happy, you are happy too. More time to invent stuff instead of regulatory work.

Quality
Perspective

Orcanos Quality Perspective

you get better compliance management with the up-to-date regulatory-wise tools in a holistic environment.

R&D
Perspective

Orcanos R and D Perspective

when your compliance officer is happy, you are happy too. More time to invent stuff instead of regulatory work.