Quality Operations
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Pharma Manufacturing · US Site GxP Engine Online
Batches Evaluated
1,284
▲ 31 today
Certified / Released
96.3%
▲ within spec
Blocked
38
OOS · deviation · excursion
Held / QP Review
9
awaiting QP certification
Live Decision Feed policy-driven · real time
Evaluate batch-release and quality events through the NUL engine, one at a time or as a live batch. Each is checked against the compiled policy graph (GMP, 21 CFR Part 11, deviation control, data integrity) and returned with a binding decision: RELEASE, HOLD, or QP REVIEW, in real time, traceable to the governing clause.
Evaluate a single event
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PROCESSED
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RELEASED
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HELD
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AVG LATENCY
Decision Mix last 24h
Every decision below is policy-driven and clause-traceable. Nothing is hand-coded into a workflow.
Decision Stream idle
Press Run Live Batch to stream decisions through the engine.
These policies were ingested as written documents (FDA regulations, EU GMP Annexes, 21 CFR Part 11, and internal release SOPs) and compiled into the executable policy graph. No one hand-coded these rules into a workflow. NUL reads the source and the rule becomes the runtime. Every batch decision traces back to one of these clauses.
EU GMP Annex 1
21 CFR Part 11
Deviation Control SOP
OOS Procedure
Data Integrity ALCOA+
Batch Release SOP
Held for QP Certification 9 open · sorted by risk
Batch B-2241 · dissolution out of spec
CQA below lower limit, OOS investigation required
HOLD
Batch B-2240 · open deviation unresolved
Cannot certify with deviation in open state
HOLD
Batch B-2239 · audit-trail gap
Part 11 record incomplete, integrity review
QP
Batch B-2242 · environmental excursion
Cleanroom excursion logged during fill
QP
Batch B-2236 · borderline assay
Within spec, QP confirmation requested
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Decision Mix by policy domain
Audit Explorer every transaction decision · immutable · clause-traceable
| Timestamp | Decision | Event & Reason | Trace |
|---|---|---|---|
| 09:42:11 | HOLD | Batch B-2241 · dissolution result out of specCQA below lower limit, release blocked pending OOS | OOS §6.1 |
| 09:41:55 | QP REVIEW | Batch B-2239 · audit-trail gap, Part 11Electronic record incomplete, integrity review | Part 11 §11.10 |
| 09:41:38 | RELEASE | Batch B-2238 · all CQAs within specClean record, no condition triggered | Release SOP §3 |
| 09:41:12 | HOLD | Batch B-2240 · open deviation unresolvedCannot certify while deviation is open | DEV §4.2 |
| 09:40:47 | RELEASE | Batch B-2237 · routine release, clean recordAll parameters within validated range | Release SOP §3 |