Settings

Current user administration and quality-SLA configuration, plus clearly labelled reference/planned settings.

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System Configuration

User administration and feature-gated quality-SLA targets are server-backed. Organization-profile fields and the permissions matrix are read-only/reference surfaces. Server authorization is authoritative — a static reference matrix must not be treated as proof of access control.

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User Management

Admins can invite users, manage account status, adjust quality roles, and create password reset links. Access control is part of GMP system control — users should have the least access needed for their role, and inactive accounts should not remain enabled. Review the user list after staffing changes and before audits.

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Imports and Configuration

Import tools and configuration controls help populate controlled records while retaining validation feedback. Bulk changes can create widespread data quality issues if source files are incomplete or mapped incorrectly — check import summaries and validation errors before relying on imported data for production or inspection evidence.

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Validate and import CSV

Settings → Imports is administrator-only and requires onboarding imports to be enabled. The Users import option additionally requires bulk user import. An unavailable tab or option is not activated by this release.

1. Select the record type and download its Template. Preserve the required headers and prepare no more than 400 data records.
2. Paste the CSV. For documents, use draft status or leave status empty; approved and in-review documents are not accepted as imported states.
3. Select Validate only. Review the returned physical CSV row numbers and each row’s diagnostics.
4. Correct invalid rows, or proceed only if your procedure permits importing the valid subset.
5. Select Import CSV, then check the committed counts, invalid rows, and created-record links.

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Validation is recorded, not committed import work

Each successful Validate only request saves one validation batch and one audit event, even when some rows are invalid. Repeating validation saves another record. The displayed would be inserted and would be updated counts are predictions. No imported documents, deviations, CAPAs, users, invitations, or email jobs are created by validation. The saved report records zero committed inserts and updates, plus separate predicted counts. Its invitation option records your selection only; it does not mean invitations were sent. Recent activity may label the event dry_run. Validation can fail if its audit record cannot be saved, including an audit lock or write failure. Do not treat that failure as a saved validation result.

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Partial success and file rejection

A structurally valid CSV can contain invalid records. Those rows are reported while valid records can be imported; an invalid document status does not abort the other valid drafts. A malformed file, an invalid header set, or a file over the limit is refused instead. These are different outcomes. A transactional failure during actual import is not partial validation success: the failed transaction rolls back its writes. Check the returned result before retrying to avoid re-importing records that already committed. Use the validation result’s parsed rows; the pre-submit line counter can include blank lines.

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User import choices

Existing active users are not updated unless Update existing active users is selected. Rows that cannot be applied are reported. You cannot alter your own account through this import. A live user import requires a reason of at least 10 characters. Send invitations after the import commits applies to the actual user import only. A queued invitation is not evidence of delivery. Validation never sends it.

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Invitations and account status

Administrators can withdraw an outstanding invitation or deactivate an account through the available user controls. Withdrawal invalidates the pending invitation; a previously issued link must not be used afterward. Deactivation also handles outstanding invitation state. Review the action’s result, rather than treating an old email link as current access. The optional invitation-status column requires invitation visibility to be enabled. This release does not enable it for every account and does not change the sign-in model.

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Sites and licences

Where multi-site administration is enabled, creating a first-time site or licence does not require a reason for changing an existing record. Later controlled changes, such as updates, archiving, or unlinking, retain their reason requirements. Site setup is not a production-system integration.

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Document categories

When document categories is enabled, administrators can add categories or rename them in Settings. Creating a category is a first-time action; renaming it requires a reason. The current controls do not delete or archive categories. See Document categories for assignment and controlled-change limits. These optional controls remain unavailable where their feature is off.