21 CFR Part 11 · EU Annex 11 · WHO-GMP

Index every batch dossier.
Pass every audit.

Zenblock Labs is the on-premise batch record archive and audit-readiness console for pharmaceutical manufacturers. Replace shelves of paper dossiers with a validated, queryable, signature-locked index.

On-Premise Deployment·Air-Gapped Capable·AES-256 At Rest
Batch Record · Locked
Clean
BN/2026/04/0187
Paracetamol IP 500mg · Tablet
Alkem Laboratories
Facility
Hyderabad — Block C
QC AR Number
AR/26/HYC/04412
Mfg Date
12 Apr 2026
Indexed
12 Apr 2026 · 14:22 UTC
Audit Trail Enabled · Signed by J. Chen

The Platform

One archive. Every dossier. Inspection-ready in seconds.

Tamper-evident archive

Every committed dossier is hashed, locked and append-only. Reason-for-change captured on every read.

Inspector-grade search

Find any batch by number, brand, AR, GRN or date in under a second — even across multi-site rollouts.

Operational checklist

Warehouse packet, QC printouts and operator signatures verified before the record can be committed.

Electronic signatures

Part 11 compliant signing with role, reason and timestamp. Counter-signature workflows out of the box.

Floor lookup

Read-only mobile view for QA officers on the shop floor. Scan a batch number, view the dossier metadata.

On-premise & air-gapped

Deploy inside the plant network. No outbound calls. Encrypted at rest with daily validated backups.

Built for regulators

Designed against the standards that matter to your QA Head.

  • 21 CFR Part 11 electronic records & signatures
  • EU Annex 11 computerised systems
  • WHO GMP Annex 5 data integrity (ALCOA+)
  • Schedule M (revised) batch record retention
  • Tamper-evident audit trail with reason-for-change
Validation Posture
IQ / OQ / PQ
Documented
URS Traceability
Maintained
Backup
Daily, encrypted
DR RPO / RTO
24h / 4h
Penetration Test
Annual
Vendor Audit
Available

The Console is designed for validated workstations.

Indexing, signing and audit review happen on QA terminals (≥1024px). On the shop floor, QA officers use the read-only Floor Lookup on handheld scanners and phones.