Solutions · Change Control
Engineering changes in days, not weeks
Replace email chains and spreadsheet BOMs with structured ECO/ECN workflows, automatic BOM impact analysis, and auditable digital signatures — all connected to your digital twin.
The Problem
Why engineering changes are painful
Change orders live in email
Engineering sends a PDF, manufacturing replies with questions, quality asks for test data. Three weeks later, no one knows the current status or who is blocking the approval.
BOM impact is guesswork
When a component changes, engineers manually search spreadsheets to find affected assemblies. They miss one, and production builds 200 units with the wrong part before anyone notices.
No audit trail for compliance
During an ISO 9001 or FDA audit, the quality team spends days reconstructing who approved what and when. Signatures are scattered across emails, shared drives, and paper forms.
Workflow
A structured path from draft to closure
Every ECO follows a configurable workflow. No step is skipped. No approval is lost.
Draft
Initiator creates the ECO, attaches affected items, and writes the justification.
Impact Analysis
System auto-populates affected BOMs and linked documents. Initiator reviews and adjusts.
Review
Parallel review by designated stakeholders. Each reviewer can approve, reject, or request changes with inline comments.
Approval
Final approvers apply digital signatures (21 CFR Part 11 compliant). Conditional approvals supported.
Released
BOM revisions are automatically incremented. Production is notified. Old revision is archived.
Closed
Post-implementation verification. Effectiveness check documented and linked to the ECO.
Capabilities
Everything you need for auditable change control
BOM Impact Analysis
- Where-used search finds every assembly containing an affected part
- Side-by-side BOM revision comparison with highlighted diffs
- Automatically populate the ECO affected-items list from where-used results
- Impact tree visualization showing cascading effects across BOM levels
Parallel Approval Workflows
- Configure review stages: serial, parallel, or mixed
- Per-reviewer due dates with automated reminders
- Delegate authority when a reviewer is out of office
- Escalation rules for overdue approvals
Digital Signatures
- 21 CFR Part 11 compliant electronic signatures
- Signature meaning captured (Approved, Reviewed, Authored)
- Tamper-evident audit log — every action timestamped and immutable
- Configurable signature requirements per workflow stage
Compliance & Audit Trail
- Complete history: who changed what, when, and why
- Export audit packages as PDF for ISO 9001, FDA, RoHS reviews
- ECO cycle time reporting: average days per stage, bottleneck identification
- Overdue approval dashboard with automatic escalation
Results from change control deployments
73%
Reduction in average ECN cycle time
0
Missed BOM impacts since deployment
< 5 min
Time to generate audit package
100%
Digital signature coverage
Connected to your digital twin
When a production defect is traced to a specific BOM revision, the ECO is initiated directly from the twin's alarm history — pre-populated with asset context, defect data, and the affected part number. No manual cross-referencing.
See change control in action
Walk through a live ECO workflow with your own BOM data in a 30-minute demo.