---
description: Qualio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！
image: https://gdm-localsites-assets-gfprod.imgix.net/images/capterra/og_logo-e5a8c001ed0bd1bb922639230fcea71a.png?auto=format%2Cenhance%2Ccompress
title: Qualio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) > [Qualio](/software/134050/quality-management-software)

# Qualio

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> 医療機器メーカー、製薬企業、バイオテクノロジー企業向けのQMS。FDA、ISO、GxPの規準に100%準拠します。文書管理、トレーニング、CAPA、不適合報告 (NCR)、監査などの処理を5倍スピードアップできます。
> 
> 評価：138人のユーザーによる評価は**4.6/5**。**おすすめ度**で最高の評価。

-----

## 概要

### Qualioの対象ユーザー

品質を重視しながらFDA、ISO、GxP規準にシームレスに準拠することを検討しているライフ・サイエンス企業 (スタートアップ企業から大企業まで)。

## 簡単な統計と評価

| 測定基準 | 評価 | 詳細 |
| **総合評価** | **4.6/5** | 138 レビュー |
| 使いやすさ | 4.5/5 | レビュー全体に基づく |
| カスタマー・サポート | 4.7/5 | レビュー全体に基づく |
| 価格の妥当性 | 4.4/5 | レビュー全体に基づく |
| 機能 | 4.3/5 | レビュー全体に基づく |
| おすすめ率 | 80% | (8/10 おすすめ度) |

## 企業情報

- **キャプテラについて**: Qualio
- **ロケーション**: San Francisco, アメリカ
- **設立**: 2010

## ビジネスコンテキスト

- **対象となる企業**: 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
- **サポートされる言語**: イタリア語, スペイン語, ドイツ語, フランス語, 英語
- **利用可能な国**: アイスランド, アイルランド, アメリカ合衆国, アルゼンチン, イギリス, イタリア, インド, ウクライナ, エクアドル, オランダ, オーストラリア, オーストリア, カナダ, ギリシャ, コロンビア, スイス, スウェーデン, スペイン, チリ, デンマーク さらに15件

## 機能

- Risk Analysis
- Third-Party Integrations
- アクセス制御・許可
- アラート／通知
- インシデント管理
- クレーム管理
- コラボレーションツール
- コンプライアンス管理
- コンプライアンス追跡
- タスク管理
- ダッシュボード
- テンプレートのカスタマイズ
- 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・キャプチャ
- ドキュメント・ストレージ
- ドキュメント管理
- バージョン管理
- ファイル共有
- フォーム管理
- フルテキスト検索
- ポリシー管理
- メンテナンス管理
- モニタリング
- リスク・マネジメント
- リスク評価
- レポートと統計
- ワークフロー管理
- 不適合追跡
- 品質管理
- 変更管理
- 変更計画
- 承認ワークフロー
- 是正措置・予防措置 (CAPA)
- 根本原因解析
- 検索／フィルター
- 機器管理
- 点検管理
- 監査管理
- 監査計画
- 監査証跡
- 評価管理
- 達成、リテンション
- 電子署名

## 統合 (合計18件)

- Asana
- Azure DevOps
- ComplianceWire
- Confluence
- GitHub
- GitLab
- Google Workspace
- HubSpot CRM
- Intercom
- Jira
- Microsoft 365
- Okta
- OneDrive
- Salesforce Sales Cloud
- TestRail

... さらに3件の統合

## 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
- 24時間対応（オペレータ）
- 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)
- [変更管理ツール](https://www.capterra.jp/directory/30958/change-management/software)
- [オンライン研修ツール](https://www.capterra.jp/directory/10008/training/software)
- [コンプライアンスシステム](https://www.capterra.jp/directory/30110/compliance/software)
- [CAPAシステム](https://www.capterra.jp/directory/31343/corrective-and-preventive-action/software)

## 代替製品

1. [QT9 QMS](https://www.capterra.jp/software/97557/qt9-quality-management) — 4.8/5 (124 reviews)
2. [Connecteam](https://www.capterra.jp/software/153140/connecteam) — 4.6/5 (5308 reviews)
3. [360Learning](https://www.capterra.jp/software/211429/360learning) — 4.7/5 (508 reviews)
4. [Dot Compliance](https://www.capterra.jp/software/192574/dot-compliance) — 4.4/5 (94 reviews)
5. [Mitti (by SafetyCulture)](https://www.capterra.jp/software/141080/iauditor) — 4.6/5 (355 reviews)

## レビュー

### "Great Software" — 5.0/5

> **Mickey** | *2022年1月27日* | バイオテクノロジー | おすすめ評価：9.0/10
> 
> **良いポイント**: It is extremely straight forward to use.  You can train managers quickly on it and use/adoption rate is very high.
> 
> **改善点**: It is a bit pricey.  However it is more versatile and easier to use than most major software - worth the extra costs.
> 
> It is very useful for anyone with or working towards ISO certification.  Very audit friendly - would recommend.

-----

### "A Great Quality Management System to get you started." — 5.0/5

> **Karl** | *2023年8月15日* | 薬品 | おすすめ評価：7.0/10
> 
> **良いポイント**: Qualio has a great user interface for anyone needing to create, edit, review, find and extract documents from a reliable document control system.  This experience also spills over to their events module allowing me to personalise an audit and risk functionality that fit the mould of my companies quality journey.  The Customer Service both supporting the induction of the platform and the every day query customer service is outstanding and could not compliment them more.  The Help features of the platform make it easy for me to find quick assistance on what I need to do and the regular webinars are a blessing for me to understand what is in production to improve my experience with Qualio.  Sandbox environment is great and much welcomes to play around before doing something you will regret in the live environment.
> 
> **改善点**: Qualio still have some sticking points with the document creation journey and while they are improving every day, they are still sorely lacking ease with the creation, reviewer and approval experience.  Supplier event is also brand new and not quite the finished product yet.  But its heading in the right direction.
> 
> I have been with Qualio for more than a year now and my company have bought into their first Quality Management System for the first time thanks to Qualios fantastic interface and ease of use.  That is the priority for any QMS.

-----

### "Qualio is a great flexible QMS tool for small companies" — 3.0/5

> **Neil** | *2023年8月16日* | バイオテクノロジー | おすすめ評価：7.0/10
> 
> **良いポイント**: Qualio has great customer service and and the onboarding team was incredibly helpful in setting up the system quickly.   The system has great flexibility in setting up customized processes using their Events feature and I'm excited to implement their new analytics features.  The process for change control is simple and intuitive.
> 
> **改善点**: As compared to other eQMS systems, there seems to be some basic functionality that is missing.  For example, change control must be applied to one document at a time where most eQMS can revise multiple documents at a time.  The system does unfortunately have bugs throughout all of their modules and the editing tool and tracking changes tool is quite tedious and burdensome.  Lastly, their design control module is really a requirements management tool and does not actually assist with design control.
> 
> Overall, my experience with Qualio is positive and I would recommend other small business owners to purchase this system.  The system was fairly easy and quick to implement and covers the basics of what is needed to establish an ISO based QMS.  The customer service is excellent and it appears that they are trying to improve both the quality of the product and the features.

-----

### "Customer Questionnaire" — 5.0/5

> **Lowell** | *2023年8月8日* | 医療機器 | おすすめ評価：10.0/10
> 
> **良いポイント**: Aesthetically pleasing, Ease of use, ease of support, at a competitive cost. Qualio meets all expectations. Qualio gives us the ability to work remotely. This seems like the norm since Covid but the last few years cannot erase generations of employees being required to be in a brick in mortar location to work. Having our products available throughout the world keeps a little stability during a US economic downturn.
> 
> **改善点**: There is not a well defined way to get feedback to the Qualio team for improvement suggestions. The Qualio has addressed my ideas but there needs to be a ticket system with feedback from the suggestion. This just needs to be addressed as a system. A ticker could be made in Qualio and assigned to the IT department. The idea can be approved or denied. The ticket can be closed. Super simple.
> 
> 100% document implementation into Qualio. Internal and third party audits directly from Qualio. Complete integration into Qualio for SD team and the sales and marketing team.

-----

### "Qualio as a Quality Management Software" — 5.0/5

> **David** | *2023年8月3日* | 医療機器 | おすすめ評価：8.0/10
> 
> **良いポイント**: User interface and scalability/adaptability to business needs
> 
> **改善点**: Inability to lock values and text fields in Events and documents.  Inability to run reports, or export data for tracking/reporting outside of Qualio.  Interface with other data sets.

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## リンク

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