Create and Release a Document

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The following walkthrough connects the reference sections by following one SOP from creation to an effective, trained document. Each step points to the section that covers it in full.

Figure 1: Document version status bar showing the completed release stages
  1. Confirm the category exists
    Ensure a suitable category exists (for example, Quality Management), and create one if necessary. (See Categories)

  2. Create the master document
    From the category, add a new master document: enter a Name, set QMS Type = SOP, confirm the Prefix, and set the Criticality Index that determines how often it must be reviewed. Who authors, reviews, approves, and is trained on the document is defined through its Access Management. (See Categories / Master Document Setup)

  3. Create the first version
    In the Initial Version Creation dialog, start from a template (for example, SOP Template (Word)) or an empty file. The version is created with status Draft. (See Version Create)

  4. Author the content
    Open the file in Word. Use the Content Manager panel to insert any variables and references, and to generate a reference list if required. (See Variables)

  5. Start the release
    On the saved version, select Document Release to open the Document Release Process. In Document Information, set the Review Mode and Approval Mode, choose the approvers (and reviewers, where review applies), then select Start Release and confirm with your Signature PIN. (See Start a Release)

  6. Review and approve
    Where reviewers are assigned, they review the version and sign first. The approver then opens the Approval section, selects Approve, confirms the attestation, and signs with the Signature PIN using Sign. (See Approve/Reject a Release / Document Approvals)

  7. Plan and release
    At the Release Plan And Training stage, set the Effective Date and Next Review Date, then select Save & Close to release automatically on the effective date, or Release Document Immediately to release now. (See Plan a Release)

  8. Assign and complete training
    Training is generated for the version from its Target Audience at the Release Plan And Training stage. Before the version becomes effective, the target audience complete their training (reading the document and, where configured, answering its questionnaire) from the Dashboard, with progress monitored in Training. (See Training Assignment / Status & Tracking)

  9. The version becomes effective
    On its effective date the new version becomes Effective, and the previously effective version becomes Obsolete.

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