SolutionsRegulated industries
Project management for regulated industries that need a trail, not a task list
When a customer or an auditor asks who approved a deliverable, a board of tasks is not an answer. Sigmaviu stores the project, the controlled document, the quality record, and the suggested control mapping with a person still deciding what gets applied.
Quality, compliance, and PMO leads in life sciences, industrial, and other regulated delivery.
Quality · NCR / CAPA
Quality loop
NCR
What broke
7 open
CAPA
The fix
3 due
Verify
Did it hold
92%
A person closes the loop — nothing auto-closes
What changes
01
Approval matches the risk
Document workflows follow the risk class. The version stays put while the workflow is open.
02
Separation of duties
Authors and owners can be blocked from approving their own document, policy, or daily report.
03
Suggestions you accept
Compliance copilot can suggest which project, document, or quality record supports a control. Nothing is written until a person applies it.
Snapshot
NCR / CAPA board
Operational quality — not certified auditor output
| Record | Type | Status | Due |
|---|---|---|---|
| NCR-118 | NCR | Open | Fri |
| CAPA-042 | CAPA | In fix | Next week |
| NCR-101 | NCR | Verifying | Today |
| CAPA-033 | CAPA | Closed | — |
Distribution
How Sigmaviu handles this
Document governance
Control number, version, risk class, and an optional signature on a critical final approval.
Quality records
Nonconformances, CAPA, and industry packs for contexts such as ISO 13485, IATF 16949, and public sector sit in the quality hub.
Framework mapping
Suggestions can draw on tasks, documents, changes, NCRs, policies, training, and tickets for ISO 9001, ISO 27001, SOC 2, HIPAA, and GDPR.
Evidence export
One-click evidence packs and a public-sector style programme pack assemble what you already filed. They are audit-prep exports, not an auditor’s opinion.
A working sequence
1
Classify
Set the document or change at the right risk.
2
Approve
Route it to someone who is not the author.
3
Map
Review suggested controls and apply or dismiss each one.
4
Export
Build the pack from the records you kept during the work.
Scope
Using Sigmaviu does not certify you to ISO, SOC 2, HIPAA, or GDPR. Nightly control scans stay off until an admin opts in. A person applies every mapping.
Questions buyers ask
Will AI file a control mapping for me?
No. Suggestions wait for Apply or Dismiss. The nightly scan is off unless you enable it.
Can the author approve their own SOP?
Document settings can require someone else to approve, including on critical records that ask for a signature.
Which standards can be suggested?
The copilot covers ISO 9001, ISO 27001, SOC 2, HIPAA, and GDPR mappings from records you already keep. You still own the control decision.