Every GMP-regulated pharma, nutraceutical, and food plant hits the same wall: batch records still live on paper or in scattered spreadsheets, QA reviews every page of every batch by hand, and a single missing operator initial can hold product release for days. ERPNext gives you a solid Work Order, BOM, Job Card, and Quality Inspection backbone, but core ERPNext was never built to be a 21 CFR Part 11 electronic record. It has no meaning-bound electronic signature, no immutable batch-level audit trail that survives a document amendment, and no concept of review-by-exception. That gap is exactly where an auditor writes the observation.

ECOSIRE builds a dedicated Frappe app — a proper module with its own DocTypes such as eBMR Template, Electronic Batch Record, EBR Step, Step Signature, and Deviation Flag — that sits on top of your existing ERPNext manufacturing data rather than replacing it. An eBMR Template is authored from your approved master formula and process (linked to the BOM and Work Order), then instantiated per batch so operators execute steps in sequence with enforced material, quantity, and equipment checks. Each critical step captures a 21 CFR Part 11 compliant electronic signature: re-authentication of the signer, an explicit signed meaning (performed-by / verified-by / approved-by), and a timestamp, all written to a locked signature child table. Every field change flows through hooks.py doc events (before_save, on_update, on_submit) into a tamper-evident audit trail keyed to the batch, so the full who/what/when/why is reconstructable long after submission.

The compliance logic is enforced server-side in Frappe server scripts and whitelisted methods, not in the browser where it can be bypassed. Out-of-limit entries — a weight outside tolerance, a temperature excursion, a skipped verification — are flagged automatically as deviations, which drives review-by-exception: QA reviews only the flagged exceptions instead of re-reading a clean batch end to end. Client scripts guide operators through the executing record, gate step completion until prerequisites and signatures are satisfied, and surface calibration or environmental-monitoring status inline. We link each step to the relevant equipment and instrument records so a batch cannot be signed off against an out-of-calibration asset, and scheduler events can watch calibration due-dates and monitoring windows. Role profiles and DocType permissions separate operator, verifier, QA reviewer, and QA release authority, and the whole record set is reachable through the Frappe REST API and whitelisted methods for LIMS, MES, or reporting integrations. It targets ERPNext v15 and v16.

Because this is build-to-order, nothing ships until we understand your process. It starts with a scoping call to map your master formula, signature meanings, deviation rules, and release workflow, followed by a fixed-scope build against your ERPNext version. We deliver on a staging site for UAT, run the validation dry-run with your QA team, then install on production with a rollback plan. Typical delivery is one working week from confirmed scope. You receive the installable source, a git repository handover, and a post-go-live support window — you own the code and can hand it to any Frappe developer afterward.