Annual quality reviews in minutes, not months.
BatchCortex aggregates every batch, every deviation, every sensor reading into a regulatory-ready PQR document. AI writes the executive summary. Your QP signs it.
EU GMP Chapter 1 §1.10 · ICH Q10 · 21 CFR 211.180(e)
The document every inspector asks for
What is a PQR?
A Product Quality Review is a mandatory annual review of all batches manufactured for a given product. It evaluates process performance, deviation trends, CAPA effectiveness, and whether your process remains in a validated state of control.
Why does it matter?
Inspectors ask for it. EU GMP Chapter 1 §1.10, FDA 21 CFR 211.180(e), and ICH Q10 all require periodic product reviews. A weak PQR is one of the most common audit findings in pharmaceutical manufacturing.
How BatchCortex automates it
Select a product and date range. BatchCortex aggregates every batch, every sensor reading, every deviation — runs Cpk analysis, Nelson rules, OOS/OOT detection, and trend regression — then generates an AI-written executive summary. Your QP signs it.
Enterprise-grade statistical analysis. Not just charts.
Every method used in BatchCortex PQR is validated for pharmaceutical process monitoring by FDA and EMA guidelines.
Cpk Process Capability
4-tier rating system: Unacceptable (<1.0), Marginal (1.0–1.33), Capable (≥1.33), Excellent (≥2.0). Monthly Cpk trends show capability over time. Flags parameters that need attention before inspectors do.
Nelson Rules
Six statistical rules that detect non-random variation in your process data. Consecutive points on one side of the centerline, alternating patterns, points beyond 2σ — BatchCortex flags them all automatically.
OOS / OOT Detection
Out of Specification values trigger investigation. Out of Trend values — within spec but drifting toward the warning zone — trigger enhanced monitoring. Both are broken down by parameter with event-level detail.
Linear Regression
Every parameter gets a trend classification: stable, increasing, or decreasing. Based on slope and R² goodness-of-fit. Catches slow drift that visual inspection misses.
Deviation Severity
Automatic classification from ML confidence scores. Critical (≥85% confidence or failure mode detected), Major (≥60%), Minor (everything else). Aggregated by type, parameter, and month.
CAPA Effectiveness
Tracks which corrective actions actually worked. Recurrence rate calculation identifies deviation types that keep coming back. Flags overdue CAPAs and measures closed-on-time percentage.
AI writes the first draft. Your QP owns the final word.
Mistral AI generates the executive summary and recommendations based on the statistical analysis. Every output is clearly labeled as AI-generated and requires human review before it becomes a GMP record.
What the AI generates
- Executive summary covering process capability, deviation trends, and CAPA effectiveness
- Mandatory action items — each assigned to a role, with a deadline, and a verification method
- Regulatory conclusions: validated state of control, revalidation recommendations, specification changes
- Triggered by data: Cpk < 1.33, Nelson violations, OOS events, yield < 95%, or FPR > 30%
Annex 22 Compliant
- Human-in-the-loop: QP must sign
- Model disclosed: mistral-large-latest
- Labeled: "AI-Generated Draft"
- Non-critical: advisory only
Compare this year to last year. Automatically.
Every PQR is automatically linked to the previous review for the same product. No manual lookup, no spreadsheet comparisons.
- Automatic linkage to the previous PQR for the same product
- Yield rate delta — year-over-year change at a glance
- Deviation count comparison across review periods
- Cpk parameter-by-parameter: improved or degraded flags for every critical parameter
- Trend continuity — see if last year's issues were resolved or persisted
Built for inspectors.
EU GMP Chapter 1 §1.10
Mandatory periodic product quality review — BatchCortex generates the full document
ICH Q10
Pharmaceutical quality system lifecycle management with process performance monitoring
21 CFR 211.180(e)
FDA annual product review requirement — same statistical rigor, same document
21 CFR Part 11
Electronic signatures on PQR sign-off with password re-authentication and SHA256 hashing
ALCOA+
Immutable records with SHA256 tamper detection, server-side timestamps, full attribution
EU GMP Chapter 4 §4.29
6-year automated retention calculated from review period end date