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Document Control

Documents up to date, correctly approved and signed off, and accessed by the right employees.

Print & Reconciliation

Developed and validated according to FDA 21 CFR 11 compliance requirements 

Trainings

Automate the process of training assignment, training completion and retraining.

Events

Easy event registration to ensure enterprise-wide quality system governance.

Equipment

Register and manage your Equipment through some very simple but efficient tools

CAPAs

CAPAs under control, implemented on time and checked for their effectiveness.

Change Control

Define a clear path to request, approve and implement change in a streamlined manner.

Competences

The tools you need to keep employee competences and CVs up to date

KPI

Intuitively create your own reports and display results to the viewers in an easy-to-understand manner.

Upcoming Modules: Audits and Risk Assessment

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QualityKick is a pre-validated solution.

This effectively takes away 95% of the validation effort on your end. What needs to be done with regards to the remaining 5%?

Validation Last Steps
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News, tips and best practices

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Product features updates, white papers, press releases...

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Why QualityKick?

Learn about the advantages of a pre-validated, cloud-based QMS solution. Check our White Paper.

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Contact us to know how we can help your company.

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The most comprehensive QMS in the market

Contact us to know more about QualityKick.

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The first cloud-based and pre-validated Quality Management Software built especially for Life Sciences


Life science companies can meet the GxP requirements using QualityKick.
We take full care to comply with 21 CFR Part 11 and EU Annex 11.
We build our solution by following GAMP-5.
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We make Quality Management easy

Writing down your quality processes is one thing, but making sure everybody is aware of them and following-up on events, CAPAs and a plethora of related actions is what keeps QA people awake at night. With QualityKick™ you can reclaim your peaceful nights again.
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Cloud-based

You connect to QualityKick™ over the internet by simply using your web browser. So, no installation is required: sign up today and start working immediately!

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Effective Support

Providing a great and fast customer service is essential in guaranteeing that our customers use QualityKick™ easily and efficiently.

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Streamline your Processes

QualityKick™ is designed to boost your company processes. You will achieve a greater level of quality efficiency.

Different QMS Modules

QualityKick™ consists of different modules which you can activate depending on your needs. Each module solves a specific part of your Quality Management processes.
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Document Control

Edit your documents comfortably with MS Word and push them through a configurable review and approval process where each relevant user is notified automatically to perform her task.

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Events

Configure different types of events like deviations, non-conformities or complaints. This module then makes it easy to register any of these events after which root cause analysis can be performed and decide if a CAPA is required.

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CAPAs

Define your CAPA plan, register CAPA actions and check its effectiveness. The automated notifications upon status change make sure that the relevant persons follow-up in a timely manner and CAPAs don’t get stuck.

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Change Control

This module enables you to create and assign all the relevant tasks of a required change to specific users. These users must then sign off on them individually. Proof can of course be uploaded and QA reviews and signs off once all tasks have been completed.

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Trainings

Know at all times who needs to be trained, and for what. Define which documents need to be read and which tasks need to be finished and leave the rest up to the trainings module to keep track of everything.

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KPI

See the performance of all your QualityKick™ Modules all in one glance.

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Equipment

Register and qualify your lab instruments or manufacturing machines and define recurring maintenance and calibration tasks. After this the Equipment module makes sure to notify the relevant persons to perform recurrent tasks and sign off on them.

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Competences

Certain jobs can only be done if an employee has certain competences. Keeping this up to date according to ongoing training programs is quite a challenge. Additionally, having up to date CV documents on file is difficult to commit to.

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Audits

When you have an e-QMS solution to manage your Documents, CAPAs and Events you are 75% ready to face a remote audit in the new norm. All you need is an Audit module to be 100% ready for internal as well as external audits to document your findings on the cloud. 

Learn about the advantages of a validated, cloud-based QMS solution
Download Whitepaper
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Great User Experience

Learn as you go with the guided tour which loads automatically when new users log in for the first time. The whole application is built with the use of only 4 layouts. If you learn how one module works you can easily find your way in all other modules. See below how the whole application has been structured.

 

  • Dashboard

  • List

  • Form

  • Detail

Dashboard 

The Dashboard is your TO DO list within QualityKick.
For each of the active modules you can see a list of items in which you have a specific role. If you need to do the next action on the item, an exclamation mark is shown in front of it. Items stay in the dashboard until the item is completely finalised. Then it leaves your dashboard and you can still find it back in the respective module.

 

List 

All list pages look exactly the same in all the QualityKick modules.
Action buttons can be found in the top left and filters in the top right. You can easily do a quick keyword search within the list and all lists are exportable in XLS or CSV format, which is handy for reporting purposes.

Form Page

Also form pages look similarly within the whole QualityKick application. When fields are not entirely self-explanatory, help texts are shown within the form. This makes the application easy to learn and keeps it user-friendly.

Detail Page

A detail page for a document, or a deviation, a CAPA or a training, looks the same in all modules as well. In a secondary column you can always see the status of the element at the top, action buttons underneath, some information, and all the rest of information and functionality has been organised in the tabs on the right.

Why Companies Choose QualityKick

Our CEO Filip Heitbrink tells you why

 “We often hear different reasons from our customers: the fact that it’s SaaS, the speed and ease-of-use of the system, and in the case of Pharma clients, because we can deliver a complete validation package along with the system. But probably the most important reason they mention is the fast and effective support. Which makes us very proud."

A picture of Filip Heitbrink, CEO of QualityKick, beside a quote of him explaining how the fast and effective support is the main reason for the costumers to contract QualityKick's QMS.

"ODTH First Class Logistics wants to profile itself as a First Class service provider in the logistics sector. To support our growth in Pharma and Life Sciences logistics, we opted for the validated document management system QualityKick. This system allows us to better monitor our processes and documents without worrying about the data integrity of the cloud system."

Rob van den Berghen
QA Manager

"We chose QualityKick first and foremost to help us reduce the time and effort we were investing to manually follow up on events and CAPAs. The fast and easy implementation of QualityKick, being this a cloud-based solution, helped us to get this part of our quality processes under control quickly."

Mark Kockx
CEO at HistoGeneX

"What I liked the most about QualityKick, was how easy it was for our employees to learn and start using QualityKick. It only required an internal training of a few hours and there very few doubts once we were live. In fact, when you know how one of the modules work, you can quickly understand the rest of the modules too."

Vicky Jasson
QA Manager

From our blog

Join our community of QA people and subscribe to our QualityKick Blog to receive great content about quality systems, QMS, cloud-based solutions, etc.

5 Life Science Companies Engaged in Incredible Research | QualityKick

on Apr 07, 2021
By Rucha Deshpande

How to handle conflict between 21 CFR Part 11 and GDPR

on Mar 23, 2021
By Rucha Deshpande

Top Ten Pharmaceutical Websites and Blogs

on Mar 16, 2021
By Rucha Deshpande

US FDA’s Proposed Regulatory Framework for AI/ML based Life Science Technologies | QualityKick

on Mar 10, 2021
By Rucha Deshpande

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