Your deviations, CAPAs, and batch records are already signed and ready.
StibaOS replaces spreadsheets, paper batches, and WhatsApp chasers with one connected system, built for Schedule M and Indian pharma MSMEs, operational from day one.
Schedule M Readiness
Live activity
Documented procedures mandated by Schedule M 2024
All coveredPenalty per finding in a CDSCO GMP inspection
Public regulatory scaleFrom signed contract to first live batch record
Implementation windowSame facility, same team — the difference is whether the evidence is already there the moment someone asks for it.
Batch records in Excel, signed in blue ink
Deviations logged in a register, CAPA lost in someone's inbox
Inspector arrives: 3 weeks of scrambling to compile records
Schedule M score unknown until the warning letter arrives
Every gap is a finding waiting to happen.
Electronic batch record with 21 CFR Part 11 e-signature
Deviation auto-routes to CAPA, closure tracked in real time
Inspector arrives: open the dashboard, show the live score
Schedule M composite score visible every morning
Walk into any inspection already ready.
Every module your facility needs, from receiving materials to releasing the batch, in one system with one audit trail.
A deviation sits in a register for weeks. The CAPA gets lost in someone's inbox.
Raised on the floor, it becomes a signed, closed CAPA before the shift ends.
Batch records are filled in after the fact, reconstructed from memory and loose notes.
Every step, yield, and signature is captured live on a tablet at the point of action.
An overdue stability pull becomes an audit finding nobody saw coming.
OOS auto-triggers an investigation; stability schedules flag every pull before it slips.
Training records and supplier docs live in scattered files when CDSCO asks.
Filings, competency sign-off, and supplier status, all tied to the batch they touch.
StibaOS tracks every Schedule M section in real time. You know exactly where you stand, long before the inspector does.
Book a 20-minute call. We'll map your facility's current gaps against Schedule M 2024 and show you exactly what StibaOS covers. No slides, no sales pitch.