Organization profile and standards

This page is for the Org admin (Grace Ooi). Other roles with Settings access can read these screens, but only the Org admin can change them.

Open Settings > Organization. The tab bar across the top of Settings has Organization, Shifts & schedule, Users & invitations, Roles & permissions, Entities & access and All master data.

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1. 1Settings tabs: Organization, Shifts & schedule, Users & invitations and more.
2. 2Company header: name, registration, timezone and a badge for each standard that is on.
3. 3On this page: choose a name to jump to that section.
4. 4Edit opens the company form.
5. 5Company details: a read-only list.
6. 6Working week: a closed day has a dashed border.

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1. 1Settings tabs scroll sideways.
2. 2Company header with the standards that are on.
3. 3On this page: a row of chips. Scroll it sideways.
4. 4Edit.

The page has five numbered sections. The On this page list at the left (a row of chips on a phone) jumps to each one:

1. Company details
2. Factories and working week
3. Standards you work to
4. Modules: see Modules and your package
5. Rules for signing and release

At the top, the company header shows the initials, the legal name, the registration number and the timezone. A badge shows each standard that is on and the number of people.

Change the company detailsCopy Anchor Link

These appear on certificates of conformance and device history records.

Set the letterhead and logoCopy Anchor Link

The letterhead is the top and the foot of the documents that you print: certificates of conformance, controlled copies of records, job travellers, device history records, first article reports and the quality manual. Each organization has its own letterhead. Open Sales > Settings > Document layout. A role with full access to Settings (by default the Org admin) can change it. Other roles can only read it.

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1. 1Logo and company details.
2. 2Footer text and registration line.

Set the operating hoursCopy Anchor Link

Under 2 · Factories and working week, seven tiles show the days with their open hours. A closed day has a dashed border. Below them, a line gives the number of factories, shifts and machines and the OEE target. Shifts & schedule opens the shifts screen.

Choose Edit hours. In the dialog, switch each day Open or Closed and set From and To. Planning, due dates and acknowledgement timers count against this time. Choose Save changes. The message reads Operating hours saved. Details of shifts and planned downtime are in Shifts, working hours and planned downtime.

Switch management system standardsCopy Anchor Link

Under 3 · Standards you work to, ISO 9001:2015 is the base standard and is Always on. The other three have a switch:

While ISO 13485 is on, six tiles show what it adds: Device history records, Advisory notices and recalls, Complaint reportability, Software validation, Retention samples and Clause references. They are part of the standard. Each reads On while ISO 13485 is on, and they are hidden when you switch ISO 13485 off. Clause references shows ISO 13485 numbers in the clause badges. When ISO 13485 is off, clause badges show the ISO 9001 equivalent.

When you switch a standard off, the app asks Switch off {name}?. Confirming hides its pages, clause badges and gates for everyone in the organization. Existing records are kept and come back when you switch it on again. The change is written to the audit trail (ISO 13485 clause 4.1).

Sign without a linked employeeCopy Anchor Link

By default, each signed step needs a login with a linked, active employee who has current training (ISO 13485 clause 6.2). A workspace that does not keep employee records can turn this check off. The Org admin makes the change. It needs a reason and your e-signature.

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1. 1Who can sign: Linked employee required is on by default.
2. 2Change opens a dialog. Only the Org admin can use it.
3. 3Before a product is released: the set and how many items.
4. 4Owner self-approval: its switch is in Purchasing settings.

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1. 1ISO 13485 warning: shown when the workspace uses ISO 13485.
2. 2Reason for the change.
3. 3Your signature.
4. 4Sign · turn off.

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1. 1ISO 13485 warning.
2. 2Sign · turn off.

When the check is off:

• A signed step does not check the employee link or the training of the person who signs.
• Each login still needs a Signs as role, and the role must have the authority for the step.
• The "someone other than" rules stay. When a login has no employee, the system compares logins. For example, the login that reported an incident cannot close it.
• Each signature shows training check off for this workspace in the record history and the audit trail.
• You can link an employee to a login that has none, but you cannot remove or change a link. Turn the check on first.
• The other Org admins get a notification. The audit trail keeps the old and the new value, the reason and the signature.

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1. 1Signing rule relaxed: on → off, with the reason.
2. 2A signature taken while the check was off says so.

You sign the change under the rule that applies at that time. To turn the check off, your own login must be linked to an active employee with current training. If your login has no employee, link one first in Users & invitations, or ask another Org admin. To turn the check on again, choose the switch, type a reason and choose Sign · turn on.

Set the product release requirementsCopy Anchor Link

The product release requirements tell the app what a product must have before you submit, approve or release it. The app also checks the same items before you issue a manufacturing order for the product. The Org admin makes the change. It needs a reason and your e-signature.

The items are:

• BOM
• Released production method
• At least one machine option
• Work instruction
• PFMEA with scored lines
• Inspection plan with a CTQ characteristic
• Process validation with an approved protocol

An open High-priority PFMEA line always stops a release and a change, for all sets. Start its action first. The sets change only whether a product must have a PFMEA.

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1. 1The set in use: Medical device by default, with the number of required items.
2. 2Change. Only the Org admin can use it.
3. 3An open High-priority PFMEA line always stops a release.

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1. 1Change for Who can sign.
2. 2The set and how many items are required.
3. 3Change for the release rules.

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1. 1Requirements set.
2. 2The first three items are always on.
3. 3The other items. Turn them on for Custom.
4. 4ISO 13485 warning: shown when an item becomes optional.
5. 5Reason for the change.
6. 6Sign · save.

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1. 1ISO 13485 warning.
2. 2Reason for the change.
3. 3Sign · save.

When you change the requirements:

• The new items apply to the next submit, approval, release and order issue. Released products stay released.
• A refusal names only the items that the set requires. For example: Product Prod Test 1 rev 1 cannot be submitted: its medical device file lacks BOM.
• When a set does not require all items, the release event of a product names the set, for example release requirements: General manufacturing (BOM, released production method, machine option).
• The other Org admins get a notification. The audit trail keeps the old and the new items, the reason and the signature (Release requirements relaxed or Release requirements changed).

You sign the change under the signing rule that applies at that time. If the rule requires a linked, trained employee, your own login must have one.

Set the process capability ruleCopy Anchor Link

Process capability (Cpk) is the PQ readings and the Min. Cpk of a process validation, and the Cp and Cpk on the SPC charts. The row Process capability (Cpk) in 4 · Rules for signing and release shows if your workspace uses it, and how many lots and readings a PQ needs. The Org admin makes the change. It needs a reason and your e-signature.

• Off: a process validation with PQ is judged on its results. The validation does not show the PQ readings or the Min. Cpk, and the approval does not ask for a Min. Cpk of 1.33. The SPC charts show the chart and the signals, but no Cp, Cpk or capability by lot.
• Fewer than 3 lots or 30 readings: type the Rationale, for example the procedure that sets the numbers: QP-7.5-02: 1 lot of 15 readings for low-risk parts. ISO 13485 7.5.6 asks for a rationale for each sample size. Each validation report shows the numbers and the rationale.
• Process capability is an add-on. If it is not part of your plan, the switch is off and you cannot turn it on. Contact VIGOR to add it.

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1. 1What the setting does.
2. 2The rule in use.
3. 3Change: Org admin only.
4. 4The rationale for numbers below 3 lots of 30.

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1. 1Use process capability: on or off.
2. 2Lots for each PQ, 1 to 5.
3. 3Readings on each lot, 10 to 100.
4. 4Rationale: needed below 3 lots or 30 readings.
5. 5Reason for the change.
6. 6Sign · save.

When you change the rule:

• The new numbers apply to the next report and approval. Validated validations keep their Min. Cpk.
• The other Org admins get a notification. The audit trail keeps the old and the new rule, the reason and the signature (Process capability relaxed or Process capability changed).

Set the line clearance ruleCopy Anchor Link

A line clearance proves that the machine has no parts, labels or material from the last order (ISO 13485 7.5.1 and 7.5.8). The row Line clearance in 4 · Rules for signing and release shows when an order needs one before setup or job start. The Org admin makes the change. It needs a reason and your e-signature.

• A clearance that someone already started for the order, Open or Cleared, is never ignored. Verify it before the order starts, whatever the value.
• Each machine records what last ran on it: the order, its product and the product revision at that moment. The system writes it when a setup starts, when a paused run resumes and when you move an order onto the machine, and when a traveller check-in scans the order in at a machine station. Only when the product changes compares the order with that record. A follow-on run needs another order of the same product at the same revision as the product has now. A new product revision, a different product or the same order again needs a clearance. Moving an order away does not clear the record of the machine it leaves. An order that already took the machine under this setting does not need a clearance again to start from the phone or to move back to it.
• The record is a change to the machine. If Maintenance edits a machine while a setup starts on it, the save can show that someone else changed the record. Reload the machine and make the edit again.
• A machine with no recorded run yet needs a clearance. This is the case for every machine until the next order is set up on it. If the system does not know the product revision, it asks for a clearance too.
• When the rule lets an order through, the Setup started and Job started events say why: Line clearance not required: follow-on run of MO-2026-1128, or Line clearance not required: not required by organization setting. An auditor sees the reason on the order.
• When the release set is Medical device and the value is not Every order, the row shows a warning. Medical device work normally needs a clearance for every order, and an auditor can raise a nonconformity.
• The other Org admins get a notification. The audit trail keeps the old and the new value, the reason and the signature (Line clearance rule relaxed or Line clearance rule changed).

See the owner self-approval settingCopy Anchor Link

The row Owner self-approval shows if the Managing Director can approve a purchase requisition that they raised. The value reads On or Off. The switch is not on this page. It is in Purchasing > Settings > Approvals, because it belongs to the purchase approval levels. Choose Open Purchasing settings to go there. Only the Org admin can change it. The system records each such approval as a self-approval. Details are in the approval ladder.

Factories and legal entitiesCopy Anchor Link

Under 2 · Factories and working week, the Factories list shows each factory. Each factory has a Code (assigned on save, for example SITE-02), Factory name, an optional Internal reference, Timezone, Location and Status (Active or Inactive). Each factory has its own timezone, shifts and machines, so add a factory before assigning shifts to it.

Entities & access (/config/tenancy) shows the tenant and deployment, the Legal entities with ID, Name, Registration, Currency, Tax and Sites, and the approval limits and delegations (see Invite people). Use + Legal entity to add one.

Run the setup wizardCopy Anchor Link

A new workspace opens the setup wizard at /setup: Company (registered name, registration number, short name, address, phone, email), Site (standards and working hours) and Team (invite people by email). Every answer can be changed later on the screens above.

If the system refusesCopy Anchor Link

Every message is in Settings refusals.

Next steps

Shifts, working hours and planned downtimeDefine when each factory runs.

• Invite people and link them to employeesGive people access.
• Settings refusalsEvery message and the fix.