To access QMS Settings, click your name in the top-right corner of the screen and select Settings. Navigate to the QMS section.
The settings below should be configured before you begin creating or importing documents, as several of them affect document numbering, approval behavior, and revision formatting in ways that are difficult to change after documents have been created.
- Enable QMS Onboarding: Set this to Yes to enable the document migration features described in Section 1.3, including metadata import, bulk ZIP file import, bulk release, and baseline training setup. Organizations building a new QMS from scratch may leave this set to No.
- Quality Manual: This setting allows you to designate a specific procedure as your organization's Quality Manual. The selected document will be surfaced in areas of the platform where the Quality Manual is referenced. This is optional and can be configured after documents have been created.
- Mandatory Approver Role: The selected QMS role is required as an approver on all controlled documents routed for approval, regardless of the approver roles configured on individual documents. This role is typically assigned to a Quality Manager or QMS Coordinator and serves as the final approval gate for all document changes. For organizations operating under ISO 13485, AS9100, or FDA 21 CFR Part 820, this setting is the primary mechanism for enforcing approval authority at the organizational level.
- Mandatory Course Approver Role: The selected QMS role is required as an approver on all Courses routed for approval, regardless of the approver roles configured on individual Courses. This setting is configured separately from Mandatory Approver Role so that training content can be reviewed by a different function, such as HR, rather than the roles who approve process documentation. Any QMS role can be selected, including the same role used as your Mandatory Approver Role, if a single approval authority is preferred.
- Mandatory Approver Controls Release: When set to Yes, only users assigned to the Mandatory Approver Role can release documents to production. Additionally, the Mandatory Approver must approve the document before any other configured approvers can submit their review. This enforces a sequential approval structure where the Mandatory Approver acts as both the first gatekeeper and the exclusive release authority. When set to No, any user with Manage Document privileges can release documents once all required approvals are obtained.
- Documents are Immediately Effective: This optional setting controls whether documents become effective immediately upon release or follow a defined effectivity workflow. It defaults to Yes, which preserves standard release behavior. When set to No, a Pending Release status is introduced into the document lifecycle between Approved and Released, and an Effective Date field becomes available on each document. Organizations that need to formally separate "released for training" from "active in production" should set this to No. See Section 2.1.10 for full details on how Document Effectivity works.
- Training Completion Threshold: This setting is only available when Documents are Immediately Effective is set to No. It defines the percentage of assigned personnel who must complete training on a document before it can be automatically released to production. The value can be set anywhere from 0 to 100. Setting this to 0 means no training completion is required before the document becomes effective on its Effective Date, which is useful for organizations that want to use the Effective Date scheduling feature without gating release on training. Any value above 0 requires that percentage of trainees to complete their assignment before the document moves from Pending Release to Released, as long as the Effective Date has also been reached.
- Use Alphabetic Revisions: Controls the revision sequence format applied to all QMS documents. When set to No (default), documents follow a numeric sequence (0, 1, 2...). When set to Yes, documents follow an alphabetic sequence (A, B, C...). Select the format that matches your organization's existing revision convention before creating or importing any documents.
- Document Numbers: This setting determines how document numbers are assigned across all document types. Select the option that fits your organization before importing or creating documents, as changing this setting after documents have been created is not recommended.
- 1factory numbers: Documents are assigned numbers in 1factory's default format, with a document type prefix followed by a sequential number (for example, PRO-1, WI-1, FRM-1). Best suited for organizations building a new QMS from scratch.
- 1factory with legacy numbers: Documents are assigned 1factory format numbers and also include a legacy number label for traceability back to the document number used in your previous system. This option supports organizations that want to adopt 1factory's numbering convention while preserving a reference to the original document number at the time of migration.
- Your own numbers: Documents follow your organization's existing numbering convention. You can define your document number prefixes per document type in the fields that appear below the selector, separated by commas. Any document created using a defined prefix will automatically receive the next sequential number for that prefix.
- Allow External Files as Documents: When set to Yes, users can upload a PDF or Microsoft Office file as the controlled document body when creating QMS documents, rather than authoring content natively in 1factory. This is the primary enabler for the bulk migration workflow described in Section 1.3. Organizations migrating an existing document library should set this to Yes before beginning the import process. Users retain the option to author documents natively in 1factory regardless of this setting.
- Periodic Document Reviews: When set to Yes, document owners can configure a review interval on each controlled document. When a review comes due, the document owner is prompted to confirm whether the document remains accurate or requires revision. This feature supports certification cycle requirements under standards such as ISO 9001 and AS9100, which require organizations to periodically reaffirm the adequacy of their documented information.
- Document Review Period: Defines how many days before a document's scheduled review due date the review process is initiated. Available options are 30, 60, or 90 days. This gives document owners advance notice so reviews are not missed ahead of audit cycles or certification renewals.