Instance: The account you work in. The instance name is displayed to the right of your name on the top ribbon when logged into Qualio.

Sandbox: A second instance of Qualio that’s provided for you to practice using Qualio or workshop different templates/workflows without affecting your primary instance. The Sandbox will also be where new features are added for validation purposes and review prior to the general availability in your primary instance.

Active User: A Normal or Quality user; someone who can actively draft content in Qualio. Active user count can be viewed in the User menu of the Admin settings.

Template: Dictates the structure and properties of your documents and events. Each particular type of document or event has its own respective template. Helps maintain consistency within your account.

Tag: A tool that allows you to group documents or events by more niche attributes in addition to the template. Tags can also be used to restrict access to documents and events if they’re associated with particular user groups. More than one tag can be added to a document or event.

Group: An identifier that can be applied by the Admin user to users within your instance. More than one group can be added to a user’s account.

Configurable: The end-user is able to dictate functionality of Qualio. Only Suppliers and Design Control areas of Qualio fall into this category due to Policy creation (Suppliers) and Integration potential (Design Control)

Customizable: The structure of individual aspects of Qualio can be adjusted but the core functionality cannot be changed by the end-user. An example of this would be a document or event: the template can be arranged as needed but the functionality of a document or event is unchanged.

Single Sign-On (SSO): Allows users to log into Qualio with only their email address via their company’s provider. This does not replace the requirement of a Part 11 compliant electronic signature.

Migrations Manager: a Qualio feature designed to manage document uploads which can then be migrated into a customer's instance. As an in-app migration tool, customers and their supporting Customer Success Representative can identify document attributes and track the progress of each migration "project" to completion.

Section: The “major headers” of your document. These dictate the structure of your document. If you were building a house, these would be your foundation and support beams.

Default Content: Content that can be added at the template level. Generally this will be instructions for what should be included in the section or any form-like structure of what’s to be completed. In our house-building metaphor, this would be your non-structural walls. All default content will automatically be populated when creating a document with this template.

Periodic Review: How often the author or Quality users should review this type of document for updates. Period begins at document approval and notification of an upcoming periodic review begins 30 days prior to the due date.

Effective: Your document is available in the Library for all your users to view.

Event: A process to capture data from Quality-based events like Complaints, NCRs, CAPAs, etc. Ability for multiple-step sign-offs, task assignment, and an overall due date to track metrics.

Content Step: A free-text step in an event that can have multiple sections (text or attachment). Default content can be set within this type of step. Same functionality as a document.

Actions Step: Step that allows the owner of the event to assign tasks to users within their organization. Each task has its own associated due date. There is no limitation on the number of tasks that can be assigned within one actions step.

Validation Step: The final step of an event. Once closed (along with all other steps in an event), the event will be complete.

Validation Step Time Delay: A timer that can be added to the Validation Step at the template level. Should only be used if you need to prevent a user from sending the final step for approval too early (for example, verification of effectiveness time period). Can be set to 0 days if not needed.

Approved Supplier List (ASL): An exportable list of all suppliers that have been Approved in Qualio.

Supplier Policy: The configurable portion of the Suppliers feature. Sets the types of suppliers, associated risk levels, required documents, and types/frequency of audits.

Supplier Policy Matrix: A visual summary of your supplier policy settings

Requirements: System artifacts used to develop product requirements. Each Product may have up to three levels of requirement and by default they are offered as; User Need, Design Input & Design Output.

Test Cases: System artifacts used to log verification & validation testing activities against product requirements. The system supports up to three levels of testing against each level of requirements but by default only level 1 (Validation) and level 2 (Verification) is enabled.

Risks: System artifacts used to log risk assessment activities against product requirements. There are two types of risk assessment available; Hazard Analysis (ISO 14971) and Failure Mode Effect Analysis (FMEA).

Design Elements: Requirements, Test Cases, & Risks

Review: Design Change Control used to collate new or modified design elements under review and to capture approval of the additions/modifications electronically.

Review Documents/Review Package: System generated design files (upon approval of a Review) populated with data from each Review. The population of these files is cumulative meaning each review builds-on and supersedes the previous review. The package contains documentation for each level of product requirement, each level of testing activity, a requirements traceability matrix and a risk analysis file.