All regulated business entities must accurately qualify vendors and track approved vendor lists to ensure that their suppliers are only qualified to provide specific products and services.
This requirement can create pain points when approved vendor lists are spread across multiple departments or divisions or are tracked manually through spreadsheets.
The Orcanos Supplier Qualification module directs all related documents, specifications, scheduled suppliers, scorecards, risk, quality events, and audits into one integrated quality management system.
With supply chain transparency a critical part of the product lifecycle, companies must be confident that all of the required documentation is managed in a single repository. With that in mind the Orcanos Electronic Supplier Management System includes the following capabilities:
Within the Orcanos supplier qualification module, vendor lists are tracked and approved in a central integrated location.
Firstly, this makes a vendor list more manageable for end users. Second, the constantly updated list of active suppliers provides a more accurate view of available resources. In addition, the integrated nature of the list helps to identify and close common or repeated gaps in supplier requirements.
To put it simply, by only working with suppliers that are willing and able to meet your specific requirements, removing unnecessary suppliers and supplementing your supplier base where needed through a network of qualified vendors, you will be able to access a significantly stronger supplier base.
Regulatory compliance is at the heart of quality processes, even more so when it comes to internal audits. The Orcanos compliance engine is here to ensure that no internal or external audit finding is overlooked.
Taking that into account, the Orcanos real-time compliance engine helps to monitor your quality processes and procedures. In essence, the module acts as a virtual or digital auditor that not only tells stakeholders what is wrong in the existing or ongoing processes, but also how these potential roadblocks can be fixed.
Understanding where gaps in the supply chain exist has become increasingly important. More often than not a company will be unaware that a part of its ecosystem may have issues, and it may be necessary to get feedback or responses from individual suppliers. This may be linked to an audit observation or change in specification, but Orcanos software allows a company to invite external contributors into the supplier module workspace to provide edits or comments.
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A complaint can generate an updated document request using Orcanos ECO module, then you can push out the changes to your supplier or workforce using a training task all of which vastly increases productivity while ensuring compliance
Generate ready-for-submission documents from your database, quickly and with a minimum of fuss
Integrate risk into your development, ensure hazards are mitigated, and prevent failure from happening, all in accordance with ISO 14971
Define e-sign processes (routing process) for documents approval, comply with 21 CFR Part 11
Powerful customization tools to customize your quality forms (CAPA, ECO, Non-Conformity, etc.), E-sign processes, status flows, mandatory rules and permissions
Build custom reports and charts to track cross-projects/cross-department reports, including 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
Embedded compliance auditor allows companies to keep track of quality processes and procedures, acting as a virtual audit that highlights mistakes and provides guidance as to how these can be fixed.