Agent 07 · record-and-review
Release faster by reviewing only what matters.
Batch-record review is a paper-heavy bottleneck that delays release and buries real deviations in routine data. The record-and-review agent surfaces the exceptions that need a human, with a complete 21 CFR Part 11 trail behind every call.
The problem
Review time is release time, and it's mostly noise.
Reviewers read thousands of in-spec data points to find the handful of deviations that matter. The result is delayed release, reviewer fatigue, and the real risk that a genuine anomaly is missed in the volume.
- Manual review reads everything to find little.
- Release delay ties up finished inventory.
- Fatigue lets real deviations slip through.
How it works
Check everything, surface the exceptions.
- 01
Aggregate the record
Every parameter from fill, lyo, inspection, and environment assembled automatically.
- 02
Verify against spec
All values checked against limits: 100% coverage, not a sample.
- 03
Surface exceptions
Only genuine deviations are escalated, each with full context.
- 04
Human disposition
A reviewer dispositions each exception; the decision is captured in the trail.
Capabilities
Release, without the paperwork.
Automated aggregation
Pulls the full electronic batch record across agents and systems.
100% verification
Every parameter checked against its limit, every time.
Exception context
Each deviation arrives with the surrounding data a reviewer needs.
Part 11 trail
Attributable, time-stamped, tamper-evident records throughout.
Trend detection
Flags drift across batches before it becomes an excursion.
Audit-ready export
Inspection-ready packages generated on demand.
Release velocity
Days of review become hours.
By reviewing 100% of data automatically and escalating only exceptions, the agent compresses release cycles and frees your most experienced people for judgment work instead of paper-reading.
See data integrity →Under the hood
Grounded, complete, defensible.
Every exception cites evidence
No unexplained flags: each escalation points to the data behind it.
100% coverage
The agent reads what humans can't: every parameter, every unit.
Part 11 by design
The trail stands up to inspection without reconstruction.
Manual review vs. Sterira
Exception-based wins.
| Behavior | Manual review | Record-and-review agent |
|---|---|---|
| Parameter coverage | Sampled | 100% |
| Reviewer focus | All data | Exceptions only |
| Release cycle | Days | Hours |
| Audit trail | Reconstructed | Continuous |
"Deviations that used to take days to find now surface in minutes, and our reviewers spend their time on judgment instead of page-turning. Release cycle time dropped by 80%."
Sterile injectables manufacturer
FAQ
Common questions.
No. It surfaces and contextualizes exceptions; a qualified person makes and records the disposition. Release authority stays with your quality organization.
It reads the electronic batch record and agent data over API, aggregating across systems. See integrations.
Yes. Attributable, time-stamped, and tamper-evident by design. See security & data integrity.
Cut days out of release.
Pilot exception-based review and measure the cycle-time drop.