キャプテラ - 日本企業の最適な
ソフトウェア選びをサポートし17年

Qualioとは?

医療機器メーカー、製薬企業、バイオテクノロジー企業により、簡単で迅速なQMS、CAPA、コンプライアンスを実現するソフトウェアと評価されています。

米国食品医薬品局 (FDA)、ISO、優良 x 規範 (GxP) の規制に準拠する80カ国以上の数百社の企業がQualioを活用することで、単一の管理しやすいソリューションで品質部門、ツール、プロセス、データを統合しています。

Qualioは、従業員と顧客向けのサービス対応を支援する業界の専門家とともに顧客を支援し、戦略を実行し、監査の準備を行い、手作業のプロセスをデジタルに変換するためのサポートを提供します。パーソナライズされたデモを今すぐリクエストください。

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)。

Qualioソフトウェア - 1
Qualioソフトウェア - 2
Qualioソフトウェア - 3
Qualioソフトウェア - 4
Qualioソフトウェア - 5

Qualioをご存知でしょうか? 別の人気製品との比較

Qualio

Qualio

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92
8
4.5 (124)
4.5 (124)
4.7 (124)
VS.
価格プラン
価格オプション
機能
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4.6 (21)
4.6 (21)
4.7 (21)
緑色の評価バーは、平均評価とレビュー数に基づいて高評価の製品を表しています。

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Qualioの評判・レビュー

評価ポイント

総合評価
4.6
使いやすさ
4.5
カスタマーサービス
4.7
機能
4.3
価格の妥当性
4.5

企業規模(従業員数)別レビュー数

  • <50
  • 51-200
  • 201-1,000
  • >1,001

評価別レビュー

5
64%
4
29%
3
6%
2
1%
Atul Pratap
Atul Pratap
インドのSales And Marketing Specialist
認証済みLinkedInユーザー
情報技術、情報サービス, 2~10人規模の会社
使用期間: 6~12か月
投稿経路

Great eQMS software

5.0 2 年前

製品を使ってみた感想: This software is a quick and effective method of managing quality procedures. The system keeps track of everything. It is suitable for small businesses and is also scalable as they expand.

良いポイント:

This software has a relatively simple learning curve. The programme has a lot of flexibility and lets you format procedures and records anyway you choose. The software contains useful features, easy-to-use interface, and finding documents is not too difficult either. Tech support is also excellent.

改善してほしい点:

It's challenging to create documents with Qualio. The formatting options could be improved. Some areas lack audit trails.

Ben
アメリカのManager of Islet Product Manufacturing
バイオテクノロジー, 11~50人規模の会社
使用期間: 6~12か月
投稿経路

Good but could be great

4.0 7 か月前

製品を使ってみた感想: 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.

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.

改善してほしい点:

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).

Neil
アメリカのSr. Director of Quality
バイオテクノロジー, 51~200人規模の会社
使用期間: 6~12か月
投稿経路

Qualio is a great flexible QMS tool for small companies

3.0 昨年

製品を使ってみた感想: 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.

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.

改善してほしい点:

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.

Neil
英国のHead of QA/RA
医療機器, 11~50人規模の会社
使用期間: 1年以上
投稿経路

Easy to use eQMS

5.0 昨年

製品を使ってみた感想: 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

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.

改善してほしい点:

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

Savneet
アメリカのSenior Quality Manager
化粧品, 51~200人規模の会社
使用期間: 6~12か月
投稿経路

Qualio set up and execution

5.0 昨年

製品を使ってみた感想: Training has become much easier.

良いポイント:

User Friendly, Team that helps you onboard and provides help along the way is amazing!! Having access to Quality specialist is a big plus and both the onboarding manager and Quality specialist have been knowledgeable, patient and great. Feedback is taken positively and shared with internal teams.

改善してほしい点:

Complaints module - having editable udf's (feedback shared with Qualio team). Document collaboration could be improved. Tag- ability to type in a tag instead of selecting from a drop-down list. Categorizing tags in the drop-down Template- linking a template in documents. Sending a template for review prior to approval Forms- Revision control. Stamping a form with the form number automatically instead of a manual addition.

Michael
アメリカのQA Director
医療機器, 51~200人規模の会社
使用期間: 1年以上
投稿経路

Excellent solution for most quality management systems

5.0 昨年

良いポイント:

Almost endless configuration capabilities allowing the creation of documents and events that fit your QMS instead of rebuilding your QMS to fit the software.

改善してほしい点:

Inability to hot-swap an approver when they are not available. Instead the document needs to be reverted to draft, the approver changed, and then the document rerouted.

Jonathan
アメリカのQuality Assurance Manager
バイオテクノロジー, 11~50人規模の会社
使用期間: 2年以上
投稿経路

Quality is in it's name and it delivers!

5.0 8 か月前

製品を使ってみた感想: I, and the company, have had a good experience with Qualio. Though there have been a few troubled spots we have always been reassured and received the improvements that have fixed issues. We are reassured that the Qualio team is working hard to give its clients the best quality management experience possible.

良いポイント:

Qualio is a platform that we've seen grow over the years. They are a team that strives to deliver a product that meets the needs of its clients and is continually improving upon past versions to deliver a product and experience that is unobtrusive to workflow at a reasonable cost. Their service team ensures you have what you need, and diligently works to implement needed changes if a feature is not available. It's clean and navigable. I highly recommend it for smaller businesses or startups.

改善してほしい点:

We have waited on occasion past a couple of feature releases for much-needed editor and supplier management changes. The review process and audit trail are good, but change control (requesting approval to create drafts, risk assessment features, and tracking changes between versions) are lacking. Sometimes it shows large chunks of text as removed and replaced when only a few changes were made. Sometimes it shows all it's changes in rich text code which is unreadable for most.

John
John
アメリカのQuality Manager
認証済みLinkedInユーザー
医療機器, 51~200人規模の会社
使用期間: 2年以上
投稿経路

Qualio helps lead the way through our MDSAP recertification audit.

4.0 3 年前

製品を使ってみた感想: 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!

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.

改善してほしい点:

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からの返信

3 年前

Hi John, congrats on your 13485/MDSAP recertification and we're ecstatic to hear positive feedback from your auditor as well!

Hanifa
ケニアのQuality Assurance Officer
薬品, 51~200人規模の会社
使用期間: 1年以上
投稿経路

The solution to management of QMS activities and Events

5.0 7 か月前

製品を使ってみた感想: It has been an interesting learning experience and the solution to the tedious manual QMS.
Work is simplified and distributed evenly.
Is a fairly lean system.

良いポイント:

Qualio has been improving every quarter to satisfy customer needs by incorporating suggestions for improvements made by customers and advancement of the feature available for use as per the current GMP regulations.

改善してほしい点:

One has to adapt very fast with the changes to enjoy the benefits. So much good not to miss out on the advantages.

chandini
インドのClinical data associate
執筆、編集, 51~200人規模の会社
使用期間: 2年以上
投稿経路

The best app for using your and reviewing your documents during your work.

5.0 8 か月前

製品を使ってみた感想: I must say that its the best and Excellent everyone must OWN.

良いポイント:

The things i like the most is the interface that the Qualio provides which is very user friendly and easy to access and its development through year is incredible

改善してほしい点:

I never saw anything that is troubling me in Qualio till date thats what made me impressed to use this daily at work.

Jigar
インドのQuality Auditor
情報技術、情報サービス, 201~500人規模の会社
使用期間: 6~12か月
投稿経路

Qualio Review

5.0 昨年

製品を使ってみた感想: Yeah, it is good to use, good to show someone your documentation and completes the process flow with respect to the features and configurations.

良いポイント:

It is the best document management system which consist of whatever things you required with respect to ISO standards and as well as the company standards. It can be configurable. Best interface, controlled documentation, easy to use and to show external parties.

改善してほしい点:

There are no such thing that i dislike, but some sort of feature incorporation while releasing a patch or full release can be taken as feedback from current users so that the new feature or full release can contains the things which are mostly required by the end users.

Robert
アメリカのQuality
医療機器, 2~10人規模の会社
使用期間: 2年以上
投稿経路

AMM Qualio Review

5.0 昨年

製品を使ってみた感想: My overall experience with Qualio is good. It has helped our company grow and pass many audits. It also helped us reduce a headcount by serving as a document control solution. Qualio solves our companies Quality Management Software needs and helps us to maintain all of our documents in a controlled system. Qualio also helps us organize our training and events such as CAPA's and NCMR's.

良いポイント:

The user interface is very good. It is easy to train new people how to use Qualio.The file organization and linking abilities from documents within documents is very good.

改善してほしい点:

I do not like how the change control history only limits you to see the last change control. If you want to see previous change control history of older versions of a document you have to create a draft and delete it once you are finished.

Cynthia
アメリカのVice President, Regulatory Affairs
医療機器, 11~50人規模の会社
使用期間: 2年以上
投稿経路

Qualio Review

5.0 3 年前

製品を使ってみた感想: I am very satisfied with Qualio.

良いポイント:

Ease of use, search feature, and the dashboards for overdue training, deviations.

改善してほしい点:

Quality events feature is a little confusing.

Qualioからの返信

3 年前

Hi Cynthia, we're happy to hear that so many of Qualio's features are enabling your QMS processes. If you'd like to provide any additional details on improvements to our Events feature, please feel free to reach out to me directly.

Kim
アメリカのQuality Specialist
医療機器, 51~200人規模の会社
使用期間: 2年以上
投稿経路

I would choose Qualio every time!

5.0 昨年

製品を使ってみた感想: The speed of being able to receive comments or suggestions within the change control process has made the process of getting documents and events approved much more quickly and efficiently.

良いポイント:

I like that it is easy to use and understand. The training documents and virtual assistance has been extremely useful in teaching new staff how to use the program.

改善してほしい点:

The formatting capability of documents and information contained in events.

Karthi
オーストラリアのHead of Manufacturing
医療機器, 2~10人規模の会社
使用期間: 1年以上
投稿経路

A true QMS for the Cloud

4.0 3 年前

良いポイント:

The level of learning required to understand Qualio is very light and I have noted that new staff learn how to use it very quickly. Being able to access the software over a browser is powerful without requiring special installations and access installed and setup on a PC.

改善してほしい点:

It is not easy or flexible to create a document in Qualio. I still find myself reaching for Microsoft Word for the first draft of a document as I am familiar with page setup options, formatting and layout in that application. Qualio is useable but highly annoying to use.

Qualioからの返信

3 年前

Hi Karthi, thank you for your review. We're happy to hear of your team's smooth onboarding process and have shared feedback regarding documentation with our product team.

Gareth
ニュージーランドのHead of Quality
薬品, 11~50人規模の会社
使用期間: 1年以上
投稿経路

Very efficient, user friendly tool for our QMS

5.0 3 年前

製品を使ってみた感想: Fantastic, coming from older clunky more expensive QMS at other Pharma companies, Qualio was a breath of fresh air.

良いポイント:

The workflows are very intuitive and with basic training a new user can navigate very easily.

改善してほしい点:

There is huge potential within Qualio to add on things like calibration management or Internal audits management. So it would be great to see additional modules / use cases added. The ability to integrate with other systems is not very visible.

Qualioからの返信

3 年前

Hi Gareth, thank you for your review and we're glad to hear Qualio has been efficient and easy to use thus far! We appreciate this insightful feedback and have shared with our product team.

Victoria
カナダのLaboratory Technician
医療機器, 2~10人規模の会社
使用期間: 6~12か月
投稿経路

A useful and up to date QMS for businesses of all shapes and sizes

4.0 昨年

製品を使ってみた感想: Qualio acts as our eQMS and streamlines our audit trail, document management, and workflows As a company with employees working in various locations, it is easy to collaborate and find documents. Overall, I do like Qualio. I feel that with time the platform will become even more useful as more features are added.

良いポイント:

I like how Qualio is constantly updating and improving. I particularly like how helpful they are with support, from webinars to onboarding support, you never feel lost of confused. Qualio does exactly what you need it to, and all the extra features are just really nice bonuses.

改善してほしい点:

There is a learning curve to figuring out Qualio in the beginning. The platform looks pretty simple and basic. but when you try to start doing advanced actions I felt lost. There is a sandbox mode, which is good for playing and learning, but anything you create in the sandbox cannot be moved into your actual account.

Daryl
英国のDirector
卸売, 2~10人規模の会社
使用期間: 2年以上
投稿経路

Qualio User Review

4.0 3 年前

製品を使ってみた感想: Has given our QMS a firm foundation

良いポイント:

After the initial 'new interface' confusion which is normal for a new application, the product is actually very easy to use

改善してほしい点:

Can't use existing documents as a template for new documents

Qualioからの返信

3 年前

Thank you for your input, Daryl! We've provided your feedback to our product team.

Judson
アメリカのPlant Manager
化学, 11~50人規模の会社
使用期間: 2年以上
投稿経路

Outstanding eQMS!

5.0 昨年

製品を使ってみた感想: We control almost every aspect of our manufacturing business in Qualio along with our MES. We love the system.

良いポイント:

We easily pass cGMP complaince audits utilizing all features of Qualio. The ease of use and being able to quickly pull up any documents requested has impressed many auditors.

改善してほしい点:

Initially the search feature was a bit clunky, but there has been improvements. No issues now.

Halyna
アメリカのQA Senior Scientist
医療機器, 51~200人規模の会社
使用期間: 6~12か月
投稿経路

Qualio customer review.

5.0 昨年

製品を使ってみた感想: Qualio is much better if compared to HQMS. Since we have Qualio we never had an issue finding the information in our Quality System.

良いポイント:

Easy to follow the directions, and create new procedures, forms, and events. Easy to find any information, approve, and review the documents.

改善してほしい点:

It is hard to create forms in Landscape format (especially if you want the form to be on one page), not possible to play with font.

Warrick
オーストラリアのsys eng
医療機器, 11~50人規模の会社
使用期間: 6~12か月
投稿経路

simple and effective

4.0 昨年

製品を使ってみた感想: Overall a huge improvement from the previous Sharepoint/paper based system.

良いポイント:

Qualio was quick to get used to for most of the workflows.

改善してほしい点:

Search functions are clunky. Document builder is ok but can be improved. Slow load time sometimes. Is there the ability to see other users draft docs? Need to be able to output the design controls into a doc and trace matrix.

Kristinn
アイスランドのRegulatory and Compliance Officer
医療機器, 51~200人規模の会社
使用期間: 1年以上
投稿経路

検討した類似製品:

Focus on being a QMS

4.0 3 年前

製品を使ってみた感想: It’s been great, especially the team behind it. They have been super helpful.

良いポイント:

That it’s focused on being a QMS and is not trying to solve all the world problems.

改善してほしい点:

It’s a little difficult to navigate at first

Qualioからの返信

3 年前

Thank you Kristinn, we're happy to hear you've had a positive experience with the Qualio team.

Jessica
アメリカのChief Commerical Officer
医療機器, 2~10人規模の会社
使用期間: 6~12か月
投稿経路

Beware, Qualio is not a Turnkey Solution

2.0 昨年

製品を使ってみた感想: The drafted documents and form templates make starting easier, but they must be tailored to the company's needs, which requires a quality person. Plus, just having the documents does not create a quality system. Please don't be fooled by the pitch that Qualio is a turnkey solution. Be aware that Qualio will not let you out of your contracted commitment.

改善してほしい点:

It is not easy to create QMS with the documents alone.

Janelle
カナダのBiomanufacturing Lead
バイオテクノロジー, 11~50人規模の会社
使用期間: 6~12か月
投稿経路

Easy to Use

5.0 昨年

良いポイント:

I like that Qualio let you keep all your documentation and training in one place, organized and easy to change when its required.

改善してほしい点:

Some of the permissions assignment are a bit cumbersome and the change control is a bit longer than it needs to be for our company at this stage.

Luke
アイルランドのLifescience Compliance Specialist
バイオテクノロジー, 2~10人規模の会社
使用期間: 1年以上
投稿経路

A User-friendly and Efficient System

5.0 昨年

良いポイント:

Qualio is extremely easy to use, with a streamlined interface that ancitipates the user's needs. In doing this, it streamlines the time required to create, edit, and access documentation in a secure way, and does not require a large amount of training or time to get used to.

改善してほしい点:

Small cosmetic and quality of life improvements are needed in specific areas, yet they are the exception to the rule in most cases and do not seriously impact the system's value.