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Wat is Qualio?

Dit cloudgebaseerde Quality Management Software (QMS) helpt biowetenschappelijke bedrijven bij het stroomlijnen van kwaliteitsprocessen, het beheren van afwijkingen en het naleven van FDA-, ISO- en GxP-voorschriften. Het platform integreert documentbeheer, CAPA, audits en nog veel meer en biedt één enkele bron van waarheid voor alle aan kwaliteit gerelateerde activiteiten. Geautomatiseerde workflows, realtime tracking en auditsporen zorgen voor transparantie en ondersteunen continue verbetering. Blijf conform en verbeter de productkwaliteit met deze uitgebreide QMS-oplossing.

Wie gebruikt Qualio?

Kwaliteits en nalevingsleiders in levenswetenschappen (biotechnologie, medische hulpmiddelen, geneesmiddelen, CxO's) die streven naar een foutloze naleving van de FDA-, ISO- en GxP-vereisten.

Waar kan Qualio worden geïmplementeerd?

Cloudgebaseerd
On-premise

Over de leverancier

  • Qualio
  • Gevestigd in San Francisco, VS
  • Opgericht in 2010

Ondersteuning voor Qualio

  • Telefonische ondersteuning
  • 24/7 (contact met medewerker)
  • Chatten

Beschikbaar in deze landen

Australië, België, Canada, Denemarken, Duitsland en nog 19 andere

Talen

Engels

prijzen van Qualio

Beginprijs:

Niet door leverancier verstrekt.
  • Geen gratis proefversie
  • Geen gratis versie

Qualio heeft geen gratis versie en biedt geen gratis proefperiode.

Prijsmodellen

Over de leverancier

  • Qualio
  • Gevestigd in San Francisco, VS
  • Opgericht in 2010

Ondersteuning voor Qualio

  • Telefonische ondersteuning
  • 24/7 (contact met medewerker)
  • Chatten

Beschikbaar in deze landen

Australië, België, Canada, Denemarken, Duitsland en nog 19 andere

Talen

Engels

Video's en afbeeldingen van Qualio

Qualio Software - 1
Qualio Software - 2
Qualio Software - 3
Qualio Software - 4
Qualio Software - 5
Nog 6 andere bekijken
Qualio-video
Qualio Software - 1
Qualio Software - 2
Qualio Software - 3
Qualio Software - 4
Qualio Software - 5

Functies van Qualio

  • Aanpasbare sjablonen
  • Afwijkingen bijhouden
  • Apparatuurbeheer
  • Archiveren en retentie
  • Auditbeheer
  • Auditplanning
  • Audittrail
  • Beleidbeheer
  • Beoordelingsbeheer
  • Bewaking
  • Compliance bijhouden
  • Compliancebeheer
  • Corrigerende en preventieve maatregelen (CAPA)
  • Dashboard
  • Documentbeheer
  • Documenten capture
  • Documenten coderen en controleren
  • Documenten opslaan
  • Elektronische handtekening
  • Formulierbeheer
  • Goedkeuringswerkstroom
  • Hoofdoorzaakanalyse
  • Incidentenbeheer
  • Inspectiebeheer
  • Klachtenbeheer
  • Kwaliteitscontrole
  • Onderhoudsbeheer
  • Rapportage en statistieken
  • Risicobeheer
  • Risicobeoordeling
  • Risk Analysis
  • Samenwerkingstools
  • Taakbeheer
  • Third-Party Integrations
  • Toegangsopties/machtigingen
  • Trainingsbeheer
  • Veranderingsbeheer
  • Versiebeheer
  • Waarschuwingen/Meldingen
  • Wijzigingsplanning
  • Workflowbeheer
  • Zoeken in gehele tekst
  • Zoeken/filteren

Alternatieven voor Qualio

Top SaaS Online Suite van toepassingen voor kwaliteitsbeheer, DocControl en opleidingsbeheer.
Stroomlijn je documentgerelateerde processen voor het schrijven, bewerken, goedkeuren en laten ondertekenen door medewerkers.
Met de eQMS van Greenlight Guru kunnen bedrijven hoogwaardige medische apparatuur veilig en snel op de markt brengen - waardoor risico's en kosten worden beperkt.
Software voor documentautomatisering zonder code om je veelgebruikte formulieren en sjabloondocumenten om te zetten in intelligente webformulieren.
De EPC van Interfacing zorgt voor volledige zichtbaarheid van auditbeheer, CAPA, regelgevende training en beheer van Standard Operating Procedures. Meer informatie over Digital Business Transformation Suite
Vertrouwd sinds 1992 met meer dan 1,6 miljoen gebruikers wereldwijd. Beheer documenten, audits, training, non-conformiteitsrapporten en corrigerende acties, ISO 9001-conformiteit en meer.
SimplerQMS is een vooraf gevalideerde en volledig conforme kwaliteitsbeheersoftware die speciaal is ontworpen voor Life Science-organisaties. Meer informatie over SimplerQMS
ServiceNow automatiseert je dagelijkse ondersteuningstaken en helpt je elke werkeenheid te volgen, meten en verwerken. Het is gebruiksvriendelijk en schaalbaar.
MRPeasy is cloudgebaseerde, betaalbare en gebruiksvriendelijke ERP-software voor productie voor kleine fabrikanten (10-200 werknemers). Meer informatie over MRPeasy

Reviews over Qualio

Gemiddelde score

In totaal
4,6
Gebruiksgemak
4,5
Klantenservice
4,7
Functies
4,3
Prijs-kwaliteitverhouding
4,5

Reviews op basis van bedrijfsgrootte (werknemers)

  • <50
  • 51-200
  • 201-1.000
  • >1.001

Reviews zoeken op score

5
64%
4
29%
3
6%
2
1%
Mickey
Mickey
Controller in VS
Geverifieerde LinkedIn-gebruiker
Biotechnologie, 11-50 werknemers
Heeft de software gebruikt voor: 6-12 maanden
Bron van de reviewer

Great Software

5,0 3 jaar geleden

Opmerkingen: It is very useful for anyone with or working towards ISO certification. Very audit friendly - would recommend.

Pluspunten:

It is extremely straight forward to use. You can train managers quickly on it and use/adoption rate is very high.

Minpunten:

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

Reactie Qualio

3 jaar geleden

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
Director Quality Assurance and Regulatory Affairs in VS
Medische apparatuur, 51-200 werknemers
Heeft de software gebruikt voor: 1+ jaar
Bron van de reviewer

Qualio as a Quality Management Software

5,0 vorig jaar

Pluspunten:

User interface and scalability/adaptability to business needs

Minpunten:

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.

Eerder overwogen alternatieven: SAP S/4HANA Cloud en Greenlight Guru

Redenen om voor Qualio te kiezen: Compliance problems with current software and poor customer support to make required changes.

Redenen om over te stappen op Qualio: Best fit needs of business at the time.

Arslan
QARA Manager in Canada
Medische apparatuur, 51-200 werknemers
Heeft de software gebruikt voor: 1+ jaar
Bron van de reviewer

Customer Support

3,0 9 maanden geleden

Pluspunten:

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

Minpunten:

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

Hanifa
Quality Assurance Officer in Kenia
Farmaceutica, 51-200 werknemers
Heeft de software gebruikt voor: 1+ jaar
Bron van de reviewer

The solution to management of QMS activities and Events

5,0 8 maanden geleden

Opmerkingen: 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.

Pluspunten:

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.

Minpunten:

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

Jonathan
Quality Assurance Manager in VS
Biotechnologie, 11-50 werknemers
Heeft de software gebruikt voor: 2+ jaar
Bron van de reviewer

Quality is in it's name and it delivers!

5,0 9 maanden geleden

Opmerkingen: 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.

Pluspunten:

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.

Minpunten:

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
GM QA and RA in Australië
Medische apparatuur, 11-50 werknemers
Heeft de software gebruikt voor: 2+ jaar
Bron van de reviewer

Quality Review

4,0 9 maanden geleden

Opmerkingen: Overall, the experience with Qualio is good so far.

Pluspunten:

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.

Minpunten:

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.

Brian
Quality Manager in VS
Medische apparatuur, 11-50 werknemers
Heeft de software gebruikt voor: 1+ jaar
Bron van de reviewer

Qualio disappointing

4,0 9 maanden geleden

Opmerkingen: 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.

Pluspunten:

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!

Minpunten:

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
software engineer in VS
Medische apparatuur, 11-50 werknemers
Heeft de software gebruikt voor: 6-12 maanden
Bron van de reviewer

Qualio review

4,0 9 maanden geleden

Pluspunten:

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

Minpunten:

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
Sr. Global Consultant QARA in VK
Medische apparatuur, 501-1.000 werknemers
Heeft de software gebruikt voor: 1+ jaar
Bron van de reviewer

Qualio Implementation

4,0 9 maanden geleden

Opmerkingen: It is mainly positive, still early days, it would have been good to have more training and a more global presence for Qualio

Pluspunten:

Document control, supplier control, CAPA control

Minpunten:

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

chandini
Clinical data associate in India
Tekstschrijvers, 51-200 werknemers
Heeft de software gebruikt voor: 2+ jaar
Bron van de reviewer

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

5,0 9 maanden geleden

Opmerkingen: I must say that its the best and Excellent everyone must OWN.

Pluspunten:

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

Minpunten:

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

Neil
Head of QA/RA in VK
Medische apparatuur, 11-50 werknemers
Heeft de software gebruikt voor: 1+ jaar
Bron van de reviewer

Easy to use eQMS

5,0 vorig jaar

Opmerkingen: 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

Pluspunten:

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.

Minpunten:

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

Eerder overwogen alternatieven: SimplerQMS

Redenen om over te stappen op Qualio: Ease of use for infrequent users, ease of implementation

Laura
VP, Quality in VS
Farmaceutica, 201-500 werknemers
Heeft de software gebruikt voor: 2+ jaar
Bron van de reviewer

Choose Qualio for your eQMS needs

5,0 vorig jaar

Opmerkingen: 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.

Pluspunten:

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

Minpunten:

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
QA Senior Scientist in VS
Medische apparatuur, 51-200 werknemers
Heeft de software gebruikt voor: 6-12 maanden
Bron van de reviewer

Qualio customer review.

5,0 vorig jaar

Opmerkingen: Qualio is much better if compared to HQMS. Since we have Qualio we never had an issue finding the information in our Quality System.

Pluspunten:

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

Minpunten:

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
Quality Consulting Service in VS
Medische apparatuur, 2-10 werknemers
Heeft de software gebruikt voor: 1+ jaar
Bron van de reviewer

Qualio review

5,0 vorig jaar

Opmerkingen: 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.

Pluspunten:

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

Minpunten:

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
Biomanufacturing Lead in Canada
Biotechnologie, 11-50 werknemers
Heeft de software gebruikt voor: 6-12 maanden
Bron van de reviewer

Easy to Use

5,0 vorig jaar

Pluspunten:

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

Minpunten:

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
Ho Regulatory and Scientific Affairs in Finland
Medische apparatuur, 2-10 werknemers
Heeft de software gebruikt voor: 6-12 maanden
Bron van de reviewer

Extremely satisfied with Qualio

4,0 vorig jaar

Opmerkingen: Overall very satisfied

Pluspunten:

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.

Minpunten:

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
Regulatory Affairs and Document Control in VS
Medische apparatuur, 51-200 werknemers
Heeft de software gebruikt voor: 6-12 maanden
Bron van de reviewer

Easy to use

5,0 9 maanden geleden

Pluspunten:

User friendly. Training, electronic signatures.

Minpunten:

Good experience so far. I like everything about Qualio.

Sharon
HR Manager in India
Computersoftware, 51-200 werknemers
Heeft de software gebruikt voor: 2+ jaar
Bron van de reviewer

Great way to manage quality

5,0 vorig jaar

Pluspunten:

Ease of use. Data storage. Ease of access

Minpunten:

The document creation can be improved...

Jessica
Chief Commerical Officer in VS
Medische apparatuur, 2-10 werknemers
Heeft de software gebruikt voor: 6-12 maanden
Bron van de reviewer

Beware, Qualio is not a Turnkey Solution

2,0 vorig jaar

Opmerkingen: 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.

Minpunten:

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

jocelyn
Materials Manager in VS
Medische apparatuur, 51-200 werknemers
Heeft de software gebruikt voor: 1+ jaar
Bron van de reviewer

Not efficient to run report

4,0 vorig jaar

Opmerkingen: Fair

Pluspunten:

It documented all the changes and updates.

Minpunten:

Can't run report or easy access to report even though the data are in Qualio. Will be great if user can run a table report and export the information into excel sheet.

Syed Aamir Ali
Mems test engineer in Finland
Halfgeleiders, 11-50 werknemers
Heeft de software gebruikt voor: 1-5 maanden
Bron van de reviewer

A useful tool

4,0 vorig jaar

Opmerkingen: the overall experience is positive.

Pluspunten:

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

Minpunten:

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

Thomas
QA Engineer in VS
Biotechnologie, 11-50 werknemers
Heeft de software gebruikt voor: 1+ jaar
Bron van de reviewer

Qualio user

4,0 3 jaar geleden

Opmerkingen: Very positive experience using Qualio. Qualio does offer weekly webinar trainings on many of the useful features. Qualio is easy to navigate.

Pluspunten:

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.

Minpunten:

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.

Reactie Qualio

3 jaar geleden

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
Associate Director of Quality in VS
Medische apparatuur, 11-50 werknemers
Heeft de software gebruikt voor: 1+ jaar
Bron van de reviewer

Good for start ups

4,0 3 jaar geleden

Opmerkingen: 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.

Pluspunten:

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

Minpunten:

Redline feature is not great right now.

Nihal
Nihal
Ceo in Kenia
Geverifieerde LinkedIn-gebruiker
Farmaceutica, 201-500 werknemers
Heeft de software gebruikt voor: 1-5 maanden
Bron van de reviewer

Qualio Review

5,0 3 jaar geleden

Opmerkingen: 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!

Pluspunten:

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!

Minpunten:

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

Cynthia
Vice President, Regulatory Affairs in VS
Medische apparatuur, 11-50 werknemers
Heeft de software gebruikt voor: 2+ jaar
Bron van de reviewer

Qualio Review

5,0 3 jaar geleden

Opmerkingen: I am very satisfied with Qualio.

Pluspunten:

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

Minpunten:

Quality events feature is a little confusing.

Eerder overwogen alternatieven: Veeva QualityOne EQMS

Redenen om over te stappen op Qualio: Cost and ease of use.

Reactie Qualio

3 jaar geleden

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.