Workspace Setup

The workspace setup wizard guides administrators through creating and configuring a new workspace. A workspace defines your organization’s quality management environment, including the industry context, applicable ISO standards, and GMP compliance requirements.

Launching the Wizard

The workspace setup wizard is accessible from the Admin panel. It opens as a full-screen modal overlay with a three-step guided process. A visual progress indicator at the top shows which step you are on.

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Step 1: Basic Information

The first step collects your organization’s core workspace details.

Workspace Name

Enter a descriptive name for the workspace. This is typically your organization or facility name.

Industry

Select your industry from the available options:

• Medical Devices
• Pharmaceuticals
• Biotechnology
• Food & Beverage
• Cosmetics
• Other

Both fields are required. You cannot proceed to the next step until both are filled in.

Note

The industry selection determines which default configurations, templates, and compliance frameworks are most relevant for your workspace.

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Step 2: ISO Standards

Select the ISO standards that apply to your organization. You can select multiple standards by checking the corresponding boxes:

Standard	Description
ISO 9001	Quality management systems
ISO 13485	Medical devices — Quality management systems
ISO 14001	Environmental management systems
ISO 45001	Occupational health and safety management systems
ISO 27001	Information security management systems
ISO 17025	General requirements for the competence of testing and calibration laboratories

Tip

Select all standards that your organization currently holds or is working toward. This helps the system tailor compliance features, training requirements, and audit checklists to your specific needs.

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Step 3: GMP Compliances

Select the GMP (Good Manufacturing Practice) compliance frameworks applicable to your operations:

Compliance	Region / Authority
21 CFR Part 820	US FDA — Quality System Regulation for medical devices
21 CFR Part 11	US FDA — Electronic records and electronic signatures
EU GMP Annex 11	European Union — Computerised systems
EU GMP Annex 15	European Union — Qualification and validation
ICH Q7	International — Good Manufacturing Practice for active pharmaceutical ingredients
PIC/S GMP	Pharmaceutical Inspection Co-operation Scheme

Review Summary

Before submitting, review the summary panel that displays:

• Workspace name
• Selected industry
• Selected ISO standards (or “None” if none selected)
• Selected GMP compliances (or “None” if none selected)

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Creating the Workspace

After reviewing the summary, click Create Workspace to finalize the setup. The system will:

1. Create the workspace with the specified configuration
2. Assign the current user as the initial administrator
3. Redirect you to the workspace on completion

Caution

Workspace name and industry are required fields. The wizard will display an error if you attempt to create a workspace without filling them in. ISO standards and GMP compliances are optional but strongly recommended.

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Navigating the Wizard

• Use the Next button to advance to the next step
• Use the Back button to return to a previous step and modify your selections
• Click the X button in the top-right corner to cancel and close the wizard without creating a workspace

The progress indicator at the top uses numbered circles connected by bars. Completed steps show a checkmark, the current step is highlighted, and future steps remain gray.