Now available for regulated manufacturers

Quality management that moves as
fast as your production lines

Resolva connects your MES, LIMS, SCADA, and ERP systems — then investigates quality events and compiles batch records automatically, with every finding cited to its exact source.

Try the live demo → Book a discovery call
21 CFR Part 11 EU GMP Annex 11 ALCOA+ ICH Q9 / Q10
The problem

Quality teams are drowning in disconnected data

Every batch spans a dozen systems. Every investigation means days of manual data collection. Resolva ends that.

70%
Time wasted on data collection
Quality engineers spend the majority of their investigation time chasing data across MES, LIMS, SCADA, and ERP — before they can even start analyzing.
4–14
Days for a manual eBR compilation
A single electronic batch record can take a week or more to assemble manually. Resolva compiles it in minutes, with every datum attributed and traceable.
<60s
Resolva's AI investigation time
From quality event reported to structured 8D/D-MAIC draft with evidence citations — under 60 seconds. Your team decides. Resolva prepares the full evidence package.
Platform features

Everything your quality team needs,
in one connected platform

From the first complaint to the closed case and archived batch record — Resolva handles the full quality lifecycle.

🔗
Universal Connector Framework
Connect any MES, LIMS, SCADA historian, or ERP via REST, OData, CSV, or MCP — visually, with no code. Every connector read is audit-logged with source record IDs.
🔍
AI Quality Investigation
Resolva queries connected systems, finds similar cases, identifies root-cause candidates, and drafts a fully-cited 8D/D-MAIC report in under 60 seconds.
📋
Electronic Batch Records
ALCOA+-compliant eBR compilation from source systems. Every datum attributed, original-sourced, and time-stamped. AI Review by Exception flags every excursion and gap.
✍️
Qualified Electronic Signature
21 CFR Part 11 §11.50/§11.200 compliant. Re-authentication + TOTP at signing. Cryptographic binding of QP identity to eBR hash. Segregation of duties enforced by code.
📊
Action Plans & Case Closure
Approved analyses automatically spawn CAPA action plans — corrective, preventive, containment. Owner assignment, due dates, reminders, and structured case closure by a QM.
🏢
Isolated Per-Customer Instances
Each customer gets their own dedicated Worker, D1, Vectorize index, and R2 bucket at their own subdomain. Zero data co-mingling — a contractual and technical guarantee.
How it works

From quality event to closed case
in four steps

1
Connect
Add your production systems in the browser — no code, no terminal. The wizard maps fields and tests the connection live.
2
Detect
Quality events arrive via email, web form, webhook, or manual entry. Triage classifies severity and product within seconds.
3
Investigate
AI queries every connected system, surfaces similar cases, and compiles a structured 8D report with full evidence citations — no hallucinations, closed-world evidence only.
4
Decide
Your Quality Manager reviews findings, approves or edits the report, assigns action items, and closes the case. The AI prepares. Humans decide.
Electronic Batch Records

The first AI-native eBR for
regulated manufacturing

eBR — BATCH-2026-001 · AI Review Report
// SCOPE OF REVIEW
connectors_queried 5 (Tulip MES, LIMS, SCADA, QMS, CMMS)
records_retrieved 47
batch_window 2026-06-10 06:00 → 14:32 UTC
// FINDINGS (3)
CRITICAL Equipment TP-007 calibration expired 2026-05-28
MAJOR Oven excursion: 188°C vs 180°C max (MBR §4.3)
info Yield 94.2% — within expected range (92–98%)
// VERDICT
band blocked
sign disabled — resolve critical finding first
// SIGNATURES
QP sign pending QA disposition
archive S3 · auto-transfer on sign
  • Full compilation from source systems Materials, equipment, process parameters, IPC, LIMS, EM, deviations — each datum traced to its exact source record and connector call.
  • AI Review by Exception 7 specialist agents run in parallel: Process Compliance, Material Genealogy, Equipment Qualification, Data Integrity, and more — each with evidence-cited findings.
  • QP sign with cryptographic binding Per-instance Ed25519 key pair. QP re-authenticates + TOTP at signing. The signature is bound to the structured record hash and PDF hash — not the session.
  • Mandatory archive to your destination S3, Azure Blob, GCS, SFTP, or SharePoint. Automatic post-transfer hash verification. Nothing is deleted from working storage until verified transfer is confirmed.
Regulatory compliance

Built from the ground up for
regulated environments

Not retrofitted for compliance — every design decision, data model, and workflow is grounded in the regulatory framework from day one.

21 CFR Part 11
Electronic records & qualified electronic signatures
EU GMP Annex 11
Computerized systems in regulated manufacturing
ALCOA+
Attributable · Legible · Contemporaneous · Original · Accurate
ICH Q9 / Q10
Quality risk management & pharmaceutical quality system
Human-in-the-loop
The AI never decides, never auto-signs.
Every release requires a human QP.
Closed-world evidence
No hallucinated data. Every finding
cites its exact source record and ID.
Append-only audit log
Every action recorded. No UPDATE,
no DELETE — ever. Exportable.
Validation package
URS, IQ/OQ/PQ scripts, traceability
matrix, risk assessment template.
See it in action

From complaint to closed case
in under 5 minutes

The demo instance runs a real quality event end-to-end — intake, investigation, 8D report, action plan, and case closure. No sign-up required.

Open live demo → Talk to the team