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。

Qualioの製品詳細

良いポイント:

Qualio is very well and highly integrated. There is a relatively short learning curve, then quite intuitive.

改善してほしい点:

It is a bit tricky to understand the management of NCRs.

Qualioの評価

評価ポイント

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

おすすめ度

8.5/ 10

Qualioの総合評価は<span class="">4.6</span>/5です。 (キャプテラに寄せられた<span class="">124</span>件のレビューより集計)。

Qualioを使用したことがありますか?

あなたのレビューを投稿しませんか?

レビューを絞り込む (124件)

Mickey
Mickey
アメリカのController
認証済みLinkedInユーザー
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

Great Software

5.0 3 年前

製品を使ってみた感想: It is very useful for anyone with or working towards ISO certification. Very audit friendly - would recommend.

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.

改善してほしい点:

It is a bit pricey. However it is more versatile and easier to use than most major software - worth the extra costs.

Qualioからの返信

3 年前

Hi Mickey, thank you for your review and we're happy to hear that Qualio has made your audit processes simpler and easier to manage.

David
アメリカのDirector Quality Assurance and Regulatory Affairs
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:

Qualio as a Quality Management Software

5.0 昨年

良いポイント:

User interface and scalability/adaptability to business needs

改善してほしい点:

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.

Arslan
カナダのQARA Manager
医療機器, 51~200人規模の会社
使用期間: 1年以上
投稿経路

Customer Support

3.0 9 か月前

良いポイント:

Customer Support is Amazing as I used to do regulars meeting with them

改善してほしい点:

Not user friendly as my CS team didn't like their complex processes

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 8 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.

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 9 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.

Muhammad
オーストラリアのGM QA and RA
医療機器, 11~50人規模の会社
使用期間: 2年以上
投稿経路

Quality Review

4.0 9 か月前

製品を使ってみた感想: Overall, the experience with Qualio is good so far.

良いポイント:

The best thing about Qualio is that you can customise it according to you own operations. The second-best thing about Qualio is their support team.

改善してほしい点:

Document management needs to be improved a bit. Resonance Health has faced a lot of issues when people with access to create drafts created drafts without prior permission and without any need of new document. This hinders the log control in Qualio.

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 9 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.

Brian
アメリカのQuality Manager
医療機器, 11~50人規模の会社
使用期間: 1年以上
投稿経路

Qualio disappointing

4.0 9 か月前

製品を使ってみた感想: Poor - I came in late (hardly anything was done) with the implementation and just wasn't aware of the capabilities of Qualio, and Qualio was backing out of the on-boarding process. I don't believe Qualio provided me with a good understanding of the capabilities of the system and how best to set it up.

良いポイント:

I do like the Document Lifecycle management and the control of documents. Need the ability to have separate libraries, (i.e for Technical Documents) and not by tag!

改善してほしい点:

Cost....Not much of a value when compared to manual systems Most everything in Qualio requires the same effort as a manual system (document control/life cycle is the exception, although some software offers version control!) I also resent the price increase applied this past year and the inability of Qualio to negotiate or justify the increase. We are actively evaluating other suppliers.

Nesh
アメリカのsoftware engineer
医療機器, 11~50人規模の会社
使用期間: 6~12か月
投稿経路

Qualio review

4.0 9 か月前

良いポイント:

I like that it is easy to use. Has good version control. It facilitates good review process

改善してほしい点:

Qualio does not keep resolved comments. When someone completes review and click ‘Mark as reviewed’ in Qualio, no email notification is received. For an existing table, adding multiple rows at a time is not possible. Only one row can be added. Unable to copy the contents across multiple rows. There is no functionality to replace one character string with another. Doesn’t notify if a particular reviewer completed review. Doesn’t allow comments by a particular reviewer if that reviewer completed review. Not possible to filter for comments from a particular reviewer. Can not add multiple rows in table. All documents in all states should be visible to all users. Can not delete comments.

Pam
英国のSr. Global Consultant QARA
医療機器, 501~1,000人規模の会社
使用期間: 1年以上
投稿経路

Qualio Implementation

4.0 9 か月前

製品を使ってみた感想: It is mainly positive, still early days, it would have been good to have more training and a more global presence for Qualio

良いポイント:

Document control, supplier control, CAPA control

改善してほしい点:

Setting up the system for our use was more complex than expected

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

Laura
アメリカのVP, Quality
薬品, 201~500人規模の会社
使用期間: 2年以上
投稿経路

Choose Qualio for your eQMS needs

5.0 昨年

製品を使ってみた感想: They have been a wonderful partner for over 5 years. I have worked with many QMS and Qualio is by far the easiest and most useful system I have ever worked with. A really important fact is that the support team at Qualio is about the best I have seen in the industry. They are responsive, well trained, and understand the criticality of getting you answers and assistance ASAP. Can't say enough about the support team... they are wonderful.

良いポイント:

Qualio is simple to implement, maintain, deploy and use. It has a very straightforward administration and implementation.

改善してほしい点:

As with any QMS, there are small things that could be improved. The editor is constantly being improved - which is great. One of the things that might have the most impact is if they could tailor it to "manager" users... so managers could see their employees training on procedures... assign documents for training, etc. instead of needing to go through the system administrators.

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.

Stephanie
アメリカのQuality Consulting Service
医療機器, 2~10人規模の会社
使用期間: 1年以上
投稿経路

Qualio review

5.0 昨年

製品を使ってみた感想: Implementing Qualio was easy, especially with the prewritten SOP's that could be adapted to the client needs. Qualio has been great for maintaining the quality system from Complaints, NCR's, CAPA's etc.

良いポイント:

Templates are helpful in guiding content creation across the organization. Events are great for managing approvals and maintaining evidence.

改善してほしい点:

Training module doesn't provide a matrix type status, i.e. Documents versus all used and training requirements/status. Document identification did not allow for using predicate quality system document numbers.

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.

Riikka
フィンランドのHo Regulatory and Scientific Affairs
医療機器, 2~10人規模の会社
使用期間: 6~12か月
投稿経路

Extremely satisfied with Qualio

4.0 昨年

製品を使ってみた感想: Overall very satisfied

良いポイント:

The whole management of quality system became so pleasant with Qualio compared to manual QMS. All the way from the purchase to implementation to going live all the needed support was available.

改善してほしい点:

The process of implementing experienced some hick-ups with Qualio's change of employees... Document creation and management is still a bit non-optimal because text modification as in e.g., Microsoft Word is quite limited

TAYDIS
アメリカのRegulatory Affairs and Document Control
医療機器, 51~200人規模の会社
使用期間: 6~12か月
投稿経路

Easy to use

5.0 9 か月前

良いポイント:

User friendly. Training, electronic signatures.

改善してほしい点:

Good experience so far. I like everything about Qualio.

Sharon
インドのHR Manager
コンピュータ・ソフトウェア, 51~200人規模の会社
使用期間: 2年以上
投稿経路

Great way to manage quality

5.0 昨年

良いポイント:

Ease of use. Data storage. Ease of access

改善してほしい点:

The document creation can be improved...

Peggy
台湾のACRM
バイオテクノロジー, 11~50人規模の会社
使用期間: 1年以上
投稿経路

User

5.0 昨年

良いポイント:

The plamform is simple. It can be sorted and search by keyword. Any new training, it will release letter to inform users.

改善してほしい点:

1) Training vedio can not be watched in the platform.2) CAPA creation is make by special users. When I use VeevaVault before, it can be created by any users.3) For almorst due training, I do not see the reminder letters. (maybe I missed them.)

Fabio
スイスのVP Technology
薬品, 11~50人規模の会社
使用期間: 6~12か月
投稿経路

Very good user interface, ease of access and responsive tool

4.0 昨年

製品を使ってみた感想: Overall QMS management efficacious and well used by the whole company

良いポイント:

Easiness to find the documents and manage deviations/CAPAs

改善してほしい点:

Customizing reminders not possible, this is useful to increase compliance and respect deadlines

Syed Aamir Ali
フィンランドのMems test engineer
半導体, 11~50人規模の会社
使用期間: 1~5か月
投稿経路

A useful tool

4.0 昨年

製品を使ってみた感想: the overall experience is positive.

良いポイント:

This software is very useful regarding providing security and organizing all the documents which can be very helpful for a company.

改善してほしい点:

Sometimes for training the documents are shaped in a complicated way, when they can deliver the point much easier way.

Thomas
アメリカのQA Engineer
バイオテクノロジー, 11~50人規模の会社
使用期間: 1年以上
投稿経路

Qualio user

4.0 3 年前

製品を使ってみた感想: Very positive experience using Qualio. Qualio does offer weekly webinar trainings on many of the useful features. Qualio is easy to navigate.

良いポイント:

Qualio is very customizable. We have built our QMS using Qualio and being that it is cloud based it is available in house or remotely. Documents are easily shared with other members of the team. The support staff at Qualio is outstanding.

改善してほしい点:

I feel if Qualio had a bulk download feature where you are able to do a download of all of the documents to a secondary location for data redundancy, that would be helpful. Currently you can download the documents, but is is a single download, and not the entire QMS.

Qualioからの返信

3 年前

Hi Thomas, thank you for your wonderful review and we're so happy to hear you're enjoying Qualio's customizable features and easy navigation. We're sharing your feedback regarding bulk downloads to our product team.

Kristi
アメリカのAssociate Director of Quality
医療機器, 11~50人規模の会社
使用期間: 1年以上
投稿経路

Good for start ups

4.0 3 年前

製品を使ってみた感想: Overall, as a small startup it worked for our needs. As we grew and more people from larger companies joined, there were struggles. I think if you are open to making Qualio work for you and you have stakeholders onboard during implementation its great. If you bring people in who are used to expensive widely used tools its a learning curve. I would use it again if I were starting a company.

良いポイント:

I liked the ability to build and edit the event flows (NCR, CAPA, etc).

改善してほしい点:

Redline feature is not great right now.

Nihal
Nihal
ケニアのCeo
認証済みLinkedInユーザー
薬品, 201~500人規模の会社
使用期間: 1~5か月
投稿経路

Qualio Review

5.0 3 年前

製品を使ってみた感想: We have a very high Qa workload and especially during inspections were reliant on a couple of people. One thing forgotten or not done on time can lead to critical or major reviews. We want to avoid that and also ensure the QA managers are using their time effectively and not chasing paper. We are still
Completing implementation and will be able to measure the efficiency, time saved and capacity developed by end of the year!

良いポイント:

I think the ease of implementation and support. Ease of use… “does what it says”. We still need more time with it but my employees seem excited about it!

改善してほしい点:

I am not sure at the moment. There were some Minor hitches with implementation . But no feedback on this yet!

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.