Get Real-time Auditor not just tells you what is wrong but also tells you how to fix it
The Orcanos supplier qualification module helps wrap all related documents, specifications, scheduled suppliers, scorecards, risk, quality events, and audits into one integrated quality management system.
Regulated businesses must accurately qualify vendors and track approved vendor lists as their suppliers are only qualified to provide specific products and services.
Traditionally this can become problematic when approved vendor lists are spread across multiple departments or divisions or track manually with spreadsheets.
The Orcanos Electronic Supplier Management System includes the following capabilities: Secured electronic, and centralized web-based system; Tractability to other quality processes, such as Nonconformance, FMEA, Training, Verification, Complaints, CAPA, etc; Smart dashboards; Workflow and e-sign automation, etc.
With the Orcanos supplier qualification module, vendor lists tracked and approved in a central integrated location. In addition to making your vendor list more manageable, an updated list of active suppliers provides a more accurate view of available resources. It helps to identify and close common gaps in supplier requirements. By only working with suppliers that are willing and able to meet your requirements, removing unnecessary suppliers, and supplementing your supplier base where needed through a network of qualified suppliers, you’ll gain a significantly stronger supplier base.
Use the Orcanos compliance engine to assure no audit finding overlooked. Orcanos real-time compliance auditor helps to watch your quality processes and procedure complying at all-time acting as a virtual auditor that not just tells you what is wrong but also tells you how to fix it.
If you need to collect responses from individual suppliers due to an audit observation or a specification change, the self-registration guest connect feature allows you to invite them into the supplier module workspace to offer edits or comments.
MDSAP Series of Articles Overview
RISK MANAGEMENT (01) – INTRODUCTION TO QUALITY RISK MANAGEMENT (QRM)
Engineering Change Order (ECO)
Orcanos Quality Management System (QMS)
Support during the COVID-19 pandemic
CAPA Chapter V: Reviewing The CAPA System and Actions
Why Design Control Is Important For Medical Devices?
Document Control Software Systems
No More Paper Work
Combine design control with quality and regulation in a central repository for better collaboration
Easily generate ready for submission documents from your database
Integrated Risk Management
Integrating risk into your development ensures that hazards are mitigated, and prevents failure from happening, all in accordance with ISO 14971
Define e-sign processes (routing process) for documents apporval, comply with 21 CFR Part 11.
Powerful customization tools to customize your quality forms (CAPA, ECO, Non-Conformity), E-signature processes, status flows, mandatory rules and permissions
Build custom reports and charts to track cross-projects/cross-department reports, such as requirements traceability, test run results, risk status, CAPA and more
Link any artifact in your process, such as requirements to test cases, risk to complaint, CAPA to ECO and track missing traceability
Alerts come into play when process-critical inconsistencies occur, such as new risk or outdated documents. Alerts are automatically fired once a day/week