Software, by the problem you're solving.
CAPA. Electronic batch records. 21 CFR Part 11. GMP. HACCP. FSMA 204. Each page is the buyer's checklist — and the exact controls, records and reports V5 produces for it.
Ingredient weighing & batching
Kiosk-led ingredient weighing and batching software for regulated manufacturers — connected scales, tolerance enforcement, electronic dispensing records, GMP-validated formulation. Replaces paper batch sheets and SCADA-only batching.
Training management software where the matrix is the gate, not a wall poster.
Training management software that ties every SOP, role and machine to a live skills matrix — and locks the kiosk when a cert lapses. 21 CFR 211.25 / 820.25 / ISO 13485 §6.2 ready.
Internal audit software where every finding lands in CAPA
Internal audit software that schedules, executes and closes findings on one platform — with auto-routed CAPAs and exportable inspector packs. Replaces iAuditor + spreadsheets.
Equipment calibration software that locks out overdue instruments.
Equipment calibration software that tracks every instrument, schedules every calibration, captures as-found/as-left readings, and locks out overdue equipment automatically.
Complaint management software that decides MDR reportability
Complaint management software with built-in MDR decisioning, CAPA linkage and full traceability to the lot, the operator and the design record. 21 CFR 820.198 ready.
Document control software
FDA document control software for SOPs, work instructions, forms and specifications — with versioning, e-signature approval, training links and Part 11 audit trail.
CAPA software that closes findings
CAPA software that links every corrective action to the deviation, the lot, the person and the proof — and forces effectiveness check before close. 21 CFR 820.100 ready.
Electronic batch record software
Electronic batch record software that assembles the EBR as the line runs — scan-gated, e-signed, exception-driven review. Replaces paper BMRs. 21 CFR 211 + Annex 11.
21 CFR Part 11 software
21 CFR Part 11 software with tamper-evident audit trails, ALCOA+ records, validated e-signatures, and a full IQ/OQ/PQ pack. Built for FDA-regulated manufacturers.
More pillars on the roadmap — MES for pharma, quality management and more.
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