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 one working week 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.