产品详细信息以英文显示。翻译即将推出。
速览
- 价格
- $799.00 USD
- Odoo 版本
- 17, 18, 19
- 设置时间
- 20160分钟
- 许可证
- 一次永久
- 语言
- 11 语言
一次性购买
Electronic Batch Manufacturing Record (eBMR) for Pharma
GMP electronic Batch Manufacturing Records in Odoo — stage-wise QC, e-signatures, lot genealogy, and full audit trail. Built to order.
$799.00USD
现在无需付款。此操作会向我们的团队发送报价请求——我们会通过邮件跟进价格和后续步骤。
核心功能
Electronic Batch Manufacturing Record generated per mrp.production lot, linked to the Master Batch Record / BoM and the specific stock.lot being produced
Configurable stage/phase structure (dispensing, granulation, compression, coating, filling, packaging, etc.) with a state-machine that enforces correct sequence and prevents skipping steps
Stage-wise QC and in-process control (IPC) capture — record weight, pH, hardness, moisture, LOD, assay and other checks against defined spec limits with automatic pass/fail flagging
21 CFR Part 11-style electronic signatures with signature meaning (Performed / Reviewed / Approved / Released), password re-authentication at signing, and a locked signed timestamp
Immutable audit trail on every field — captures user, old value, new value, UTC timestamp and mandatory reason-for-change, exposed via mail.thread chatter plus an append-only underlying log
Raw-material lot genealogy — each dispensed component is tied to its incoming stock.lot so you get full forward/backward traceability from raw material to finished lot
Yield reconciliation with computed fields (@api.depends): theoretical vs. actual vs. accountable quantity, % yield, and variance thresholds that block advancement when unexplained
Deviation and non-conformance logging with severity, root-cause, CAPA reference and QA sign-off workflow, escalated by automated/server actions
Role-based access via ir.model.access.csv and record rules — Operator, QC Analyst, QA Reviewer and QA Releaser each see and can act only on what their role permits
Review-by-exception dashboard highlighting only records with open deviations, out-of-spec IPCs or reconciliation variances so QA reviews the exceptions, not every line
GMP-formatted QWeb PDF batch record export (header, stage log, IPC results, signatures, deviations) suitable for the physical/electronic batch file and inspection
XML-RPC / JSON-RPC endpoints so LIMS, external QC instruments, serialization or a parent ERP can push results into and pull the record out of Odoo
Master Batch Record / template versioning so a lot always records against the exact revision of the process instruction that was effective at production time
Configurable release checklist that hard-blocks final QA release until all IPCs are in spec, all deviations are closed, and reconciliation is within tolerance
关于此产品
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.
为什么选择 Electronic Batch Manufacturing Record (eBMR) for Pharma
Electronic Batch Manufacturing Record generated per mrp.production lot, linked to the Master Batch Record / BoM and the specific stock.lot being produced
Configurable stage/phase structure (dispensing, granulation, compression, coating, filling, packaging, etc.) with a state-machine that enforces correct sequence and prevents skipping steps
Stage-wise QC and in-process control (IPC) capture — record weight, pH, hardness, moisture, LOD, assay and other checks against defined spec limits with automatic pass/fail flagging
21 CFR Part 11-style electronic signatures with signature meaning (Performed / Reviewed / Approved / Released), password re-authentication at signing, and a locked signed timestamp
Immutable audit trail on every field — captures user, old value, new value, UTC timestamp and mandatory reason-for-change, exposed via mail.thread chatter plus an append-only underlying log
Raw-material lot genealogy — each dispensed component is tied to its incoming stock.lot so you get full forward/backward traceability from raw material to finished lot
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.
你得到什么
- Complete, installable Odoo module (__manifest__.py, models, views, security, QWeb reports) engineered to your product templates and SOPs, for your target Odoo 17/18/19 edition
- Configuration and data setup: your stage/phase structures, IPC spec limits, deviation categories, signature meanings and role/security groups mapped to your process
- Validation support package — installation/operational qualification (IQ/OQ) test scripts, requirements traceability and a Part 11 controls summary to support your CSV effort
- Technical documentation: data model, security matrix, integration/API reference and an admin configuration guide
- Operator and QA training sessions (recorded) covering record execution, IPC entry, e-signing, deviation handling and QA release
- Deployment/installation on your Odoo instance (or ECOSIRE-managed hosting), plus UAT support and a go-live cutover for your first live batches
- A defined post-go-live support and bug-fix window with response SLAs, and a documented change-request path for enhancements
- Source code ownership/licensing terms so your team (or another vendor) can maintain and extend the module later
这是给谁的
QA Manager / Head of Quality
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.
Production / Operations Manager
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.
QC Analyst / Lab Supervisor
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.
Regulatory / CSV Lead
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.
安装概述
从ECOSIRE下载
在 ecosire.com 上购买许可证并从您的帐户仪表板下载 Electronic Batch Manufacturing Record (eBMR) for Pharma 模块 ZIP。
上传至Odoo
将 ZIP 解压到服务器上的 Odoo 自定义插件文件夹中（或通过“应用程序”>“从 Odoo.sh / runbot 上的文件安装”上传）。
安装模块
激活开发者模式，打开应用程序，单击更新应用程序列表，搜索 Electronic Batch Manufacturing Record (eBMR) for Pharma，然后按安装。
配置设置
打开新菜单，粘贴您的 ECOSIRE 许可证密钥，连接任何外部凭据（Shopify、Amazon、Stripe 等），然后保存。
验证并上线
运行内置连接测试，同步前 10 条记录，并安排定期 cron。如果出现任何问题，请联系支持人员。
Electronic Batch Manufacturing Record (eBMR) for Pharma 如何比较
| 标准 | 伊科西尔 | 定制建造 | 竞争对手 | 奥杜本机 |
|---|---|---|---|---|
| GMP-structured eBMR (stage log, IPC, reconciliation) tailored to your SOPs | 包含 | 部分支持 | 部分支持 | |
| 21 CFR Part 11-style e-signatures with meaning + re-authentication | 包含 | 部分支持 | 部分支持 | |
| Immutable field-level audit trail with reason-for-change | 包含 | 部分支持 | 部分支持 | |
| Raw-material lot genealogy tied to stock.lot + yield reconciliation | 包含 | 部分支持 | 部分支持 | |
| Validation support (IQ/OQ scripts, controls summary for CSV) | 包含 | 不包括在内 | 不包括在内 | |
| Role-based access (Operator/QC/QA) via record rules | 包含 | 部分支持 | 部分支持 | |
| LIMS / instrument integration via XML-RPC / JSON-RPC | 包含 | 部分支持 | 不包括在内 | |
| Built, installed, validated and supported for you (2-4 wk) | 包含 | 不包括在内 | 不包括在内 | |
| Maintained across Odoo 17 / 18 / 19, Community or Enterprise | 包含 | 部分支持 | 部分支持 |
关于Electronic Batch Manufacturing Record (eBMR) for Pharma的常见问题
How long does delivery take, since this isn't an instant download?
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.
What support and updates do I get after go-live?
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.
Does this actually make us 21 CFR Part 11 / EU-GMP Annex 11 compliant?
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.
Will it work with our existing Odoo Manufacturing setup, or do we start over?
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.
Can QC instruments or a LIMS feed results in automatically?
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.
Does it run on Odoo Community or do we need Enterprise?
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.
What happens to our historical paper batch records?
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.
相关模块
申请报价
Electronic Batch Manufacturing Record (eBMR) for Pharma
GMP electronic Batch Manufacturing Records in Odoo — stage-wise QC, e-signatures, lot genealogy, and full audit trail. Built to order.
- Electronic Batch Manufacturing Record generated per mrp.production lot, linked to the Master Batch Record / BoM and the specific stock.lot being produced
- Configurable stage/phase structure (dispensing, granulation, compression, coating, filling, packaging, etc.) with a state-machine that enforces correct sequence and prevents skipping steps
- Stage-wise QC and in-process control (IPC) capture — record weight, pH, hardness, moisture, LOD, assay and other checks against defined spec limits with automatic pass/fail flagging
- 21 CFR Part 11-style electronic signatures with signature meaning (Performed / Reviewed / Approved / Released), password re-authentication at signing, and a locked signed timestamp