GMP electronic Batch Manufacturing Records in Odoo — stage-wise QC, e-signatures, lot genealogy, and full audit trail. Built to order. Built to order by ECOSIRE for Odoo 17, 18, 19 — indicative price from $799.00 USD; request a quote for a scoped proposal.
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GMP electronic Batch Manufacturing Records in Odoo — stage-wise QC, e-signatures, lot genealogy, and full audit trail. Built to order.
Sin configuración por tu cuenta: una app funcional creada, instalada y con soporte de ECOSIRE.
Empieza con un precio único de desarrollo. Definimos el alcance contigo en el arranque.
ECOSIRE la crea, la configura y la instala en tu Odoo.
Sales en vivo en unas 2–4 semanas, con un periodo de soporte posterior al lanzamiento.
Paper batch records are the single biggest source of GMP audit findings in pharma and nutraceutical plants — illegible entries, missing initials, transcription errors, and reconciliation gaps that only surface weeks after a lot has shipped. This module replaces the paper travelling packet with a fully electronic Batch Manufacturing Record (eBMR) built natively on Odoo Manufacturing (MRP), so your Master Batch Record, in-process controls, QC results, and release approvals live in one auditable system alongside the inventory, lots, and BoMs you already run.
This is a BUILD-TO-ORDER module, not an off-the-shelf apps.odoo.com download. ECOSIRE designs, builds, installs, validates, and supports it around your actual SOPs, product templates, and regulatory scope (WHO-GMP, EU-GMP Annex 11, US 21 CFR Part 11, or your national authority). You never receive a generic ZIP and get left to figure out the mapping — we engineer the record structure to your process.
Technically, the module introduces dedicated Odoo models (models.Model) for the batch record header, stage/phase lines, in-process control checks, QC test results, and deviations, all linked to the standard mrp.production order and stock.lot (serial/lot) records. Computed fields with @api.depends drive live yield and reconciliation math (theoretical vs. actual vs. accountable quantity, % yield, variance flags) so operators can't advance a stage with an unexplained discrepancy. Stage progression is governed by a state machine and enforced through ir.model.access.csv plus record rules, so a mixing operator, a QC analyst, and a QA releaser each see and sign only what their role permits.
Every meaningful action — value entry, correction, review, approval, release — is captured as an immutable audit-trail entry (who, what, old value, new value, UTC timestamp, reason-for-change) using Odoo's mail.thread chatter as the visible layer plus a locked, append-only log underneath, giving you 21 CFR Part 11-style electronic signatures with meaning (Reviewed / Approved / Rejected) and re-authentication at signing. Automated actions and server actions escalate open deviations, block release while an in-process control is out of spec, and notify QA. The finished record prints as a GMP-formatted QWeb PDF suitable for the batch file and regulatory inspection, and the same data is reachable over XML-RPC / JSON-RPC for LIMS, ERP, or serialization-system integration.
Built for Odoo 17, 18, and 19, Community or Enterprise. ECOSIRE delivers the code, the configuration mapped to your products, validation documentation to support your CSV/qualification effort, operator and QA training, and a support window — so the record is running in production and inspection-ready, not just installed.
Owns GMP compliance and audit readiness. Needs enforced review-by-exception, tamper-evident audit trails, Part 11 e-signatures with meaning, and one-click inspection-ready batch records — without chasing initials on paper packets.
Runs the shop floor and cares about throughput. Wants operators to record stages, weights and IPCs at the point of execution, with reconciliation that flags yield problems in real time instead of during a month-end paper review.
Captures in-process and finished-goods test results against spec. Needs a structured place to log assay, LOD, hardness and pH results, automatic out-of-spec flagging, and a signed hand-off to QA — ideally fed from LIMS over XML-RPC.
Prepares for WHO-GMP, EU-GMP Annex 11 and 21 CFR Part 11 inspections. Needs validation artifacts, a documented controls model, and confidence that the electronic record and signatures are defensible under audit.
| Criterio | ECOSIRE | Construcción personalizada | Competidor | Odoo Nativo |
|---|---|---|---|---|
| GMP-structured eBMR (stage log, IPC, reconciliation) tailored to your SOPs | Incluido | Apoyo parcial | Apoyo parcial | |
| 21 CFR Part 11-style e-signatures with meaning + re-authentication | Incluido | Apoyo parcial | Apoyo parcial | |
| Immutable field-level audit trail with reason-for-change | Incluido | Apoyo parcial | Apoyo parcial | |
| Raw-material lot genealogy tied to stock.lot + yield reconciliation | Incluido | Apoyo parcial | Apoyo parcial | |
| Validation support (IQ/OQ scripts, controls summary for CSV) | Incluido | No incluido | No incluido | |
| Role-based access (Operator/QC/QA) via record rules | Incluido | Apoyo parcial | Apoyo parcial | |
| LIMS / instrument integration via XML-RPC / JSON-RPC | Incluido | Apoyo parcial | No incluido | |
| Built, installed, validated and supported for you (2-4 wk) | Incluido | No incluido | No incluido | |
| Maintained across Odoo 17 / 18 / 19, Community or Enterprise | Incluido | Apoyo parcial | Apoyo parcial |
This is a build-to-order module, so there is no instant download — ECOSIRE builds, installs and validates it around your process. Typical lead time is 2 to 4 weeks from a confirmed requirements/SOP review, depending on the number of product types, stage structures and integrations (e.g. LIMS). We start with a scoping call, share a build plan, then deliver in UAT before go-live so you can verify it against a real batch.
Every engagement includes a defined post-go-live support window with response SLAs for bug fixes and configuration questions, plus a documented change-request path for enhancements. Because it's built on standard Odoo MRP/stock objects, ECOSIRE also maintains compatibility across Odoo 17, 18 and 19; version upgrades and new-feature work are handled as scoped follow-ons. You receive the source and licensing terms so you're never locked in.
The module supplies the technical controls Part 11 and Annex 11 require — unique authenticated e-signatures with meaning, re-authentication at signing, an immutable audit trail with reason-for-change, and role-based access via record rules. Compliance itself is a combination of software controls plus your validated procedures (SOPs, training, CSV). ECOSIRE ships IQ/OQ scripts and a controls summary to support your validation, but final qualification is performed and owned by your quality unit.
It extends what you already run. The eBMR links to your existing mrp.production orders, bills of materials, products and stock.lot records rather than replacing them, so BoMs, routings and inventory stay intact. We map the record to your current Master Batch Records and stage structures during the build, so operators recognise the flow on day one.
Yes. The module exposes Odoo's XML-RPC and JSON-RPC interfaces so a LIMS, an instrument gateway, a serialization/track-and-trace system or a parent ERP can push IPC and QC results into the batch record and read the released record out. Where a direct instrument integration is in scope, ECOSIRE builds and documents that connector as part of the engagement.
It runs on both, for Odoo 17, 18 and 19. The core eBMR, e-signatures, audit trail and QWeb reports work on Community. Some conveniences (such as certain studio-style customizations or approvals apps) are Enterprise-only in Odoo core; during scoping ECOSIRE confirms which edition you're on and builds the module so nothing critical depends on features your edition lacks.
The module governs records from go-live forward; it does not require you to re-key years of legacy paper. Historical batches typically remain in your existing archive per your retention SOP. If you need selected legacy lots represented in Odoo for traceability or reference, ECOSIRE can scope a controlled one-time data load as an add-on.
GMP electronic Batch Manufacturing Records in Odoo — stage-wise QC, e-signatures, lot genealogy, and full audit trail. Built to order.