What routes through stage gating
Everything important, not just formulas.
Records
- Products
- Packaging
- Suppliers
- Ingredients
- Fact panels
- Formulas
Stages
- Draft review
- Cross-functional sign-off
- Final approval
- Release to production
- Effectiveness checks
- Re-approval on change
Evidence captured
- Unique sign-off attribution
- Date and time stamps
- Signature meaning tied to action
- What was approved and when
- Full audit trail
21 CFR Part 11
Electronic records and signatures you can actually defend.
SKUsafe is designed to support the documentation and workflow discipline needed for Part 11 - secure audit trails, approval attribution, and controls that make electronic sign-off trustworthy and inspectable.
- Unique user accounts and attribution
- Secure, time-stamped audit trails
- Signature meaning captured per record
- Record retention & version history
- Inspectable on demand
ELECTRONIC SIGNATURE
K. Patel, QA Lead
"Approved for compliance review - v1.4"
2026-04-21 14:08:22 UTC · from 10.0.2.24 · via SSO (Okta)
See SKUsafe on your own SKUs.
30-minute walkthrough on your real data - formulation, labels, supplier control.