Runs On-Premise
Designed to install on a desktop PC inside your facility. No SaaS subscription, no cloud upload, no data leaving your premises — ever.
Pharma · Audit Readiness · Schedule M
On-premise AI for CDSCO Schedule M audit readiness
If a CDSCO inspector walked in tomorrow and asked for 90 days of deviation records and CAPAs — how long would it take to put that file together?
CDSCO's revised GMP guidelines under Schedule M are now in force. Small and mid-size manufacturers face the same compliance bar as large players — with a fraction of the QA resources.
Deviation logs are in notebooks. CAPAs are in email threads. SOPs are in a folder somewhere. When an inspector asks, the scramble begins.
Batch records and quality data leaving the facility raises its own regulatory questions. Most SaaS QMS tools weren't designed for Indian GMP requirements.
Built to run entirely on a desktop inside your facility — your data never leaves your premises
PharmaCompli is designed to walk through the revised Schedule M checklist and help you identify exactly where your current documentation and processes fall short — before an inspector does.
Log deviations as they happen, link them to CAPAs, and track closure. Every entry is timestamped and traceable, with 90-day reports generated in seconds, not hours.
Upload existing SOPs, batch records, or logs. The on-premise AI is built to flag gaps, inconsistencies, and missing mandatory elements against Schedule M requirements.
Generate a structured compliance file covering deviations, CAPAs, SOP status, and environmental monitoring — formatted for a CDSCO inspection response.
Designed to install on a desktop PC inside your facility. No SaaS subscription, no cloud upload, no data leaving your premises — ever.
Built specifically around CDSCO's revised Schedule M checklist. Not a generic QMS adapted for India — purpose-built for this regulation.
Upload documents and the local LLM is designed to flag compliance gaps — without sending your batch records or SOPs to any external server.
Generate deviation and CAPA summary reports for any date range in seconds — the file an inspector asks for, ready on demand.
Designed for air-gapped facility environments, with no dependency on internet connectivity for core compliance functions.
Track every CAPA from opening to closure with owner assignment, due dates, and evidence attachment. Nothing falls through the cracks.
Tell us about your facility and current compliance setup — we'll assess whether PharmaCompli is the right fit and what deployment looks like for you.