--- 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 Canonical: https://www.capterra.jp/software/134050/quality-management-software ページ：1 / 6\ 次へ: [次ページ](https://www.capterra.jp/software/134050/quality-management-software?page=2) > 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：129人のユーザーによる評価は**4.5/5**。**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** | **4.5/5** | 129 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 | 4.2/5 | 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**: 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, イギリス, イタリア, オランダ, オーストラリア, オーストリア, カナダ, スイス, スウェーデン, デンマーク, ドイツ, ノルウェー, フィンランド, フランス, ベルギー, ルクセンブルク ## 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 (118 reviews) 2. [MasterControl Quality Excellence](https://www.capterra.jp/software/148577/mastercontrol) — 4.5/5 (534 reviews) 3. [Dot Compliance](https://www.capterra.jp/software/192574/dot-compliance) — 4.4/5 (87 reviews) 4. [Ideagen Quality Management](https://www.capterra.jp/software/155354/Ideagen-Quality-Management) — 4.5/5 (178 reviews) 5. [SafetyCulture](https://www.capterra.jp/software/141080/iauditor) — 4.6/5 (353 reviews) ## レビュー ### "Qualio helps lead the way through our MDSAP recertification audit." — 4.0/5 > **John** | *2022年2月1日* | 医療機器 | おすすめ評価：9.0/10 > > **良いポイント**: Software is easy to use and navigate, and to train others to use at different levels. Record and report output is quick and organized. > > **改善点**: Software has presented with many fix opportunities. That said the Qualio team is quick to remediate bugs and provide module upgrades that address new user needs\! > > Qualio serves as my document repository, my "source of truth" for all required records within our 13485/MDSAP compliant QMS. Recertification was completed in 2021 and the auditor noted the speed with which all document records were presented, without a backroom runner\! ----- ### "Decent QMS support system" — 4.0/5 > **Melissa** | *2024年4月12日* | 医療機器 | おすすめ評価：6.0/10 > > **良いポイント**: I appreciate that all of the main functionalities (document management, CAPA, Complaint, Supplier Management, etc.) are available in the system. The referencing between events and between documents works very well. It's also reasonably easy to customize templates and certain workflows. I also appreciate that they are regularly improving the system and that there is good attention on providing supporting validation documentation. > > **改善点**: There are certain features that should have more control such as the implementation of new Event templates. This can be a major change to the quality system and essentially there is no workflow around it. Anyone with the access level can make the change with no review or approval. The formatting of documents is sometimes also very inconsistent and difficult to use. The final complaint is the inability to migrate from the sandbox to the production instance. > > Overall I'm satisfied with the product but I don't love it enough to recommend strongly. It's getting the job done, but I feel like that's with a number of (minor) workarounds. However, based on the experience in the last 9 months, I do expect it to continue to improve. ----- ### "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. ----- ### "Easy to use eQMS" — 5.0/5 > **Neil** | *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**: We've found Qualio is easy and intuitive for non-expert users to work with. Moving our most common forms directly into Qualio has cut out a lot of minor errors which in turn saves QA a lot of time. > > **改善点**: It took us a bit of time to get our training set up properly although that was partly because we weren't clear what our aims were. When we first started the timings and content of updates was somewhat confusing, however the new system of planned and notified release schedules has made this much simpler and easier for users > > Qualio has made our document management must simpler and easier to access. At our most recent audit, the auditor commented how much better structured our technical files were now that we had switched to Qualio ----- ### "Good but could be great" — 4.0/5 > **Ben** | *2024年4月26日* | バイオテクノロジー | おすすめ評価：8.0/10 > > **良いポイント**: Super easy to use (with one exception which I'll describe below). Great at reminding me of tasks that need completion. Easy for people to pick up with a little instruction. Onboarding was easy. > > **改善点**: The word processing portion is often frustrating. It is designed for ease of use, but coming from Microsoft word, Qualio's word processing unit is lacking in a few things. First, the toolbar is minimal. I'd like more tools when I'm formatting. Second, the formatting in the online word processing is atrocious. I have to constantly export the documents to ensure the worksheets I make aren't broken up between pages (I suggest some sort of preview of page alignment, so that I don't constantly have to DL a PDF when I'm formatting Worksheets). > > I'd rate Qualio an B+ to A-. It would be a perfect A if the word processor built into the program was a little more user friendly when it comes to formatting things like Worksheets. ----- ページ：1 / 6\ 次へ: [次ページ](https://www.capterra.jp/software/134050/quality-management-software?page=2) ## リンク - [Capterraで表示する](https://www.capterra.jp/software/134050/quality-management-software) ## このページは以下の言語で利用できます | ロケール | URL | | de | | | de-AT | | | de-CH | | | en | | | en-AE | | | en-AU | | | en-CA | | | en-GB | | | en-IE | | | en-IL | | | en-IN | | | en-NZ | | | en-SG | | | en-ZA | | | es | | | es-AR | | | es-CL | | | es-CO | | | es-CR | | | es-DO | | | es-EC | | | es-MX | | | es-PA | | | es-PE | | | fi | | | fr | | | fr-BE | | | fr-CA | | | fr-LU | | | it | | | ja | | | nl | | | nl-BE | | | pt | | | pt-PT | | | sv | | ----- ## 構造化データ