---
description: Total Lean Management (TLM) QMS Softwareを実際に使用したユーザーのレビューから、製品の機能や価格、メリットデメリットをご覧いただけます。類似製品との比較も簡単、ぴったりのSaaSが見つかるはず！
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title: Total Lean Management (TLM) QMS Softwareとは？ | 機能や料金、導入事例をご紹介【キャプテラ】
---

現在地表示: [ホーム](/) > [QMS（品質管理システム）](/directory/30099/quality-management/software) > [Total Lean Management (TLM) QMS Software](/software/21289/the-lean-machine)

# Total Lean Management (TLM) QMS Software

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> The Lean Machineは ISO 9001、13485などに対応した品質管理ソフトウェアです。堅牢で使いやすく、手頃な価格で優れたサポートを提供します。
> 
> 評価：40人のユーザーによる評価は**4.8/5**。**おすすめ度**で最高の評価。

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## 概要

### Total Lean Management (TLM) QMS Softwareの対象ユーザー

自社のQMSを無駄のない効率的かつ効果的にすることを目的として、規制要件を満たす戦略の策定を行えるパートナーを必要とする、先進的な企業。

## 簡単な統計と評価

| 測定基準 | 評価 | 詳細 |
| **総合評価** | **4.8/5** | 40 レビュー |
| 使いやすさ | 4.6/5 | レビュー全体に基づく |
| カスタマー・サポート | 5.0/5 | レビュー全体に基づく |
| 価格の妥当性 | 5.0/5 | レビュー全体に基づく |
| 機能 | 4.9/5 | レビュー全体に基づく |
| おすすめ率 | 100% | (10/10 おすすめ度) |

## 企業情報

- **キャプテラについて**: Lean & Mean Business Systems
- **設立**: 2001

## ビジネスコンテキスト

- **価格プラン**: $75.00
- **価格モデル**:  (無料のトライアル)
- **対象となる企業**: 自営業, 2～10, 11～50, 51～200, 201～500, 501～1,000, 1,001～5,000, 5,001～10,000, 10,000+
- **デプロイとプラットフォーム**: クラウド、SaaS、ウェブベース, Mac（デスクトップ）, Windows（デスクトップ）, Windows（オンプレミス）
- **サポートされる言語**: 英語
- **利用可能な国**: アイスランド, アイルランド, アゼルバイジャン, アフガニスタン, アメリカ合衆国, アラブ首長国連邦, アルジェリア, アルゼンチン, アルバ, アルバニア, アルメニア, アンギラ, アンゴラ, アンティグア・バーブーダ, アンドラ, イエメン, イギリス, イスラエル, イタリア, イラク さらに210件

## 機能

- アクセス制御・許可
- インシデント管理
- クレーム管理
- コンプライアンス管理
- コンプライアンス追跡
- トレーニング管理
- ドキュメントのコーディングおよび制御
- ドキュメント管理
- バージョン管理
- メンテナンス管理
- モニタリング
- リスク・マネジメント
- 品質管理
- 変更管理
- 是正措置・予防措置 (CAPA)
- 機器管理
- 監査管理
- 達成、リテンション

## 統合 (合計2件)

- Microsoft Outlook
- QuickBooks Enterprise

## サポートのオプション

- メール/ヘルプデスク
- FAQ/フォーラム
- ナレッジベース
- 電話サポート
- チャット対応有

## Category

- [QMS（品質管理システム）](https://www.capterra.jp/directory/30099/quality-management/software)

## 関連カテゴリー

- [QMS（品質管理システム）](https://www.capterra.jp/directory/30099/quality-management/software)
- [コンプライアンスシステム](https://www.capterra.jp/directory/30110/compliance/software)

## 代替製品

1. [Dot Compliance](https://www.capterra.jp/software/192574/dot-compliance) — 4.4/5 (94 reviews)
2. [QT9 QMS](https://www.capterra.jp/software/97557/qt9-quality-management) — 4.8/5 (126 reviews)
3. [MasterControl Quality Excellence](https://www.capterra.jp/software/148577/mastercontrol) — 4.5/5 (540 reviews)
4. [Mitti (by SafetyCulture)](https://www.capterra.jp/software/141080/iauditor) — 4.6/5 (355 reviews)
5. [Qualio](https://www.capterra.jp/software/134050/quality-management-software) — 4.6/5 (138 reviews)

## レビュー

### "Great QMS Software and the best Customer Support\!" — 5.0/5

> **Craig** | *2021年7月23日* | 医療機器 | おすすめ評価：10.0/10
> 
> **良いポイント**: Software has all the requirements for both GMPs and ISO 13485. Most modules are very easy to use. The system is very reasonably priced and customer support is top notch.
> 
> **改善点**: TLM can function on the desktop connected to a local server, or as a SaaS using solely a browser to access the system connected to a data center (hosted) database, so we really haven't had any experiences that are worth complaining about.
> 
> C2C highly recommends the Lean Machine QMS software. It meets all of the requirements for GMP and ISO 13485, easy to use and great customer support. We have gone through 2 ISO 13485:2016 audits with no issues relating to the software.

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### "The Lean Machine" — 5.0/5

> **Jim** | *2010年2月6日*
> 
> **良いポイント**: Excellent version \&amp; checkout control, management control.  The ability to designate certain classes of documents and then list per the classification is helpful.  The distribution control of controlled documents works well.&#13;&#10;&#13;&#10;We like the super fast response from customer support.  Also, the software designer is open to special improvements to assist our workflow and data integrity.  There was one instance when we were actually undergoing a FDA inspection and a version control deficiency was identified and that same day David Smithstein implemented a fix that has been made a permanent feature in the software.&#13;&#10;&#13;&#10;Of particular value to us is the quick search features that allow us to locate specific documents by various means.  In a recent FDA inspection the inspectors commented on the easy location and presentation of documentation they requested.&#13;&#10;&#13;&#10;We constantly modify our documents and the version control and saving of historical versions is excellent.&#13;&#10;&#13;&#10;Highest Recommendation\!\!
> 
> **改善点**: There are too many screens for the review and approval of existing documents.  It would be nice to have a one click "review and release" button for documents that haven't changed but require review every 12 months.&#10;&#10;The individual screens can not be increased in size.
> 
> I have recommended TLM to auditors, inspectors and fellow regulatory and quality professionals over the last 5 years.  I looked at many QMS packages when we started our company and TLM was not a front runner then, they were a small company with a fledgling product and it has grown and improved over the years into an excellent product that I am comfortable continuing to recommend.&#13;&#10;&#13;&#10;Five Stars\!

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### "The Lean Machine software has always met our company requirements as we continue to grow\!" — 4.0/5

> **Jonathan** | *2018年6月19日*
> 
> **良いポイント**: The best feature of The Lean Machine is that all of our quality system needs are managed in a single software platform. The single QM software platform ensures quality system data is easily shared by   everyone from manufacturing to quality assurance that is involved in maintaining product quality.
> 
> **改善点**: The GUI could use a make-over so it is contemporary in appearance but this is not a necessity for a utilitarian QS software platform.

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### "Outstanding product, service and support" — 5.0/5

> **Ray** | *2010年11月12日*
> 
> **良いポイント**: The Lean Machine is 10 out 10 in ease of use, flexibility, functionality, service and support.  We are currently using it to manage our clinical diagnostic lab, and with the help of David Smithstein, have been able to customize the system's function to allow us to manage our entire production process from ordering materials, through generating work orders, to managing all quality documentation, to tracking inventory and WIP, through to managing incoming patient specimens and all the way to sending patient test results, all within the Lean Machine system.  There is not a product for GMP or GLP document and manufacturing control that compares to the Lean Machine in capabilities at such an incredibly affordable price.
> 
> **改善点**: We have seen a great improvement in speed and ease of synchronization with the Lean Machine Enterprise version.
> 
> This is the second FDA regulated company that I have used The Lean Machine for managing the manufacturing process and controlling documentation.  The software has been invaluable to every facet of my production operations.  I have looked around and I am completely confident that there is not a better value out there for a system that gives complete lot number traceability, bill of material management, work order processing, and document version number control.  The incredible service and support that the company gives in addressing questions is invaluable "icing on the cake."  I am not sure when David sleeps, but his responsiveness in support is par excellence.

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### "We could not be happier with The Lean Machine, both the software AND their consulting services\!\!\!" — 5.0/5

> **Don** | *2016年8月30日* | おすすめ評価：10.0/10
> 
> A couple years ago we hired a different consultant who basically gave up on us, walked out on the project and took the money with him.  I was less than pleased, although admittedly our organization was probably a little more challenging than most as everyone was learning ISO for the first time.&#10;In contrast,  The Lean Machine and their consulting services not only got the job done at a reasonable price, but the auditors where noticeably impressed with our quality system especially since it was our first audit, AND we were being registered to the new ISO 9001:2015 standard that everyone was still trying to figure out how to interpret.&#10; &#10;Although the biggest benefit from our perspective, is that LMBS trained us on how to use the system to better control how we wanted to do things and this resulted in several process improvements that we made as a team\!&#10;Being new to ISO and all their requirements, at first we were a little overwhelmed.  The Lean Machine basically handles everything we needed, plus LMBS made several software updates along the way to support some of the new ISO requirements, which the auditors thought were spot on.&#10;Technical support was also world class.  We could call, or e-mail and receive same day service, often with a remote desktop sharing session to make sure the issue was resolved, and our technical support person was always supportive and easy to talk to.&#10; &#10;My only regret is that I'm limited to a 5 star rating'. Overall I would give them a 6\!\!\!

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