Using Qualio’s Supplier module to track and manage your third party vendors is a great way to demonstrate supplier management policies are being followed. And since Qualio is now one of your company’s applications, you’ll need to list Qualio as a supplier in Qualio. 😁
Adding Qualio as a Supplier
When adding Qualio as a supplier, use your organization’s documented Supplier Management policy and the following information as guidance.
Customers will typically list Qualio in the “cloud software” or “SaaS” category.
Qualio is our organization’s Quality Management software used for document management, training management, quality event workflows, supplier management and design controls.
We recommend listing the Quality Manager of your organization as the Sponsor.
Supplier’s Contact Information
We recommend listing your dedicated Customer Success Manager (CSM) as your contact. CSMs are responsible to manage the customer relationship and respond to product and quality requests. When and if CSM assignments change you’ll be notified and introduced to your new CSM by email / zoom call and can update the supplier record at that time.
An eQMS will typically be listed as LOW risk because it does not have a direct impact on product quality or patient safety. It is used to manage quality system processes. However, as some quality system processes have an indirect impact on patient safety, some organizations may move into a medium risk when used for pharmacovigilance/post-market surveillance activities and analytics (trend detection, etc). Note: You should have software risk levels defined in your Software Validation SOP and ensure Qualio's risk aligns with your organization's risk classifications.
How does Qualio document product changes?
Qualio has a documented Change Management policy (POL-51) and procedure (POL-81) available for customer inspection upon request. These documents detail major and minor impact changes, planned and emergency maintenance, implementation steps, and what customer communication and validation support documentation is provided for each change.
All product changes are captured in our Product Changes log, accessible from the top navigation bar for all Qualio users and highlighted with a green dot to indicate new updates. New features, feature enhancements and bug fixes are all listed along with the latest version number. Starting in 2023, additional information for Launch Train releases (new features and feature enhancements) are provided in Release Notes available on our Help Center.
Do we need a (Supplier) Quality Agreement?
Qualio has and can provide a Quality Agreement for customer signature. Some customers may require this prior to signing a contract with Qualio in addition to the Master Service Agreement. Contact your Customer Success Manager to initiate the request.
How does Qualio handle Complaints and Supplier Corrective Action Requests (SCAR)?
Qualio tracks customer reported feedback in compliance with our documented Customer Feedback procedure (SOP-87). For complaints meeting the criteria, the Quality team will create a Complaint event in Qualio to track, investigate and resolve. Complaints are reviewed in quarterly Management Reviews. Corrective actions for the complaint will be made and communicated to the originating customer as appropriate. (We highly recommend that our customers track the event/incident as a Supplier Corrective Action Request in their instance of Qualio as well.)
If Qualio determines the problem to lie with one of our suppliers/vendors, then Qualio will create a SCAR event in Qualio to track per our documented Supplier Management policy (POL-55). All departments are responsible to report questionable or poor supplier performance immediately to the Quality Team. Individual supplier sponsors work with the Quality team to resolve and SCARs are reviewed in quarterly Management Reviews to provide visibility to the entire organization. Customer communication of SCAR events is handled on a case by case basis and included in any internal or external audit.
How does Qualio handle Supplier Audits?
Our External Audit procedure (SOP-88) documents the steps and responsibilities of Qualio and the requesting body. Customers or prospects can begin the process by requesting an audit from their Customer Success or Sales representative. Please include the formal Audit Request, Audit Plan, Desk Audit or other Audit documentation to be forwarded to the Quality Ops team. The Quality Ops team will coordinate scheduling calls and other tasks with the customer.
We are happy to provide auditors limited access to Qualio’s Quality Management System for a time period preceding the dates of the audit to allow for ample preparation, and to close following the audit. Nondisclosure agreements (NDAs) or Mutual Nondisclosure agreements (MNDAs) shall be in place prior to granting access to our QMS and/or ISMS systems where a formal agreement is not already in place (such as a Master Subscription Agreement, Partner Agreement, Business Partner Agreement, etc.). The Auditor’s access will be limited to basic read-only permissions for documentation tagged with “Auditor” or "ISO Auditor" if the audit is with a notified body.
Follow-up actions, audit findings and other audit steps are further defined in our procedure documentation and at the discretion of the Quality Ops team and Qualio management. All Audit events are tracked using Qualio Events.