Compliance
GMP, Schedule M and CPCB documentation that builds itself — every shift.
BMRs, deviation logs and CAPA assembled by hand before each audit turn every inspection into a 72-hour fire drill. PlantIQ builds the records continuously, so an audit becomes a five-minute export.
Compliance is reactive because the paperwork is manual
When batch records, deviation logs and CAPA are stitched together in the days before an inspection, compliance is always a scramble and always at risk of a gap. The documentation reflects the audit calendar, not the actual production. PlantIQ inverts that: the record is generated shift by shift as the batch runs, so the plant is audit-ready by default rather than by heroics.
Audit-ready for GMP, Schedule M and CPCB — continuously
PlantIQ captures batch records, deviation trails and the data CPCB and GMP inspections ask for as a by-product of running the batch. Schedule M documentation, COA attachment, operator sign-off status and deviation history stay current in one place. When an auditor or a customer arrives, the answer is a download, not a week of preparation.
ALCOA+ posture from day one
Records are immutable once a supervisor closes the batch. Any amendment creates a new record with a reason code linked back to the original, preserving a clean, attributable, contemporaneous audit trail. The compliance narrative is built into the data model, not bolted on before an inspection.
Frequently asked
Does PlantIQ support Schedule M and CPCB requirements?
Yes. PlantIQ continuously captures batch records, deviation logs and the process data GMP, Schedule M and CPCB inspections require, keeping the plant audit-ready and turning audit prep into a short export.
Are batch records tamper-proof?
Records become immutable after supervisor close. Amendments create a new linked record with a reason code, preserving an ALCOA+ audit trail from day one.
Is this suitable for exporters facing FDA/EU-GMP scrutiny?
PlantIQ is built for mid-sized manufacturers who face rising compliance pressure, including export-rejection risk. It strengthens documentation discipline, though formal FDA/EU-GMP readiness always depends on your full quality system.
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