EURSvalidator FAQs - Frequently Asked Questions

Why should I use EXTEDO's EURSvalidator?

Trusted technology

80% of regulatory authorities in Europe and many others around the globe use EXTEDO technology for ensuring eCTD and NeeS compliance. The validation engine developed by EXTEDO is in use in the form of EURS or as stand-alone tool EURSvalidator.

These regulatory authorities use EURS/EURSvalidator.  

Flexibility

Multiple license options for individual validation requirements. You can configure your EURSvalidator license according to the country or region you want to file your submission in. You can combine different validation set packages within one license.

Available license options.

Up-to-date

We ensure you always have the latest validation set. EXTEDO cooperates closely with regulatory authorities and we guarantee that all relevant validation sets are included in the respective license packages and that validation sets are always up-to-date.

Expertise

EXTEDO is the consulting partner of choice for more than 35 regulatory authorities worldwide. Be on the safe side when it comes down to validating your medicinal or veterinary eSubmissions: Achieve the greatest possible accuracy and save time and nerves with EURSvalidator – the validation you can trust! 

What happened to GLOBALvalidator and the free download of EURSvalidator?

As of 02 June 2015 GLOBALvalidator and the free EURSvalidator download were discontinued. The new release of EURSvalidator replaces both former tools.  

Why is there a license fee for EURSvalidator now?

We decided to implement a fee-based license model in the effort to maintain the high quality of our validation tool. For many years EXTEDO has provided EURSvalidator free of charge and GLOBALvalidator at a nominal license fee respectively. However, due to continuous enhancements (e.g. addition of new validation sets, support of new standards like eCTD 4.0/RPS), the expenditures in development and maintenance of the product are far in excess of what they were a few years ago. This has prompted us to revise our product strategy.  

What is the new regional license model?

EURSvalidator is available in a regional license model, i.e. a license is applicable for a particular geographic region. The following regions are available:

  • EU North (Sweden, Norway, Denmark, Finland, Iceland)
  • EU West (France, Belgium, Netherlands, Luxembourg)
  • EU Central (Switzerland, Germany, Austria, Liechtenstein)
  • EU South (Spain, Portugal, Italy, Malta, Greece, Croatia, Slovenia, Cyprus)
  • EU East (Poland, Czech Republic, Slovakia, Hungary, Estonia, Latvia, Lithuania, Bulgaria, Romania)
  • EU UK and Ireland (United Kingdom, Ireland)
  • Switzerland (Switzerland (without eDok))
  • North America (USA, Canada)
  • Asia Pacific (all member countries of the Gulf Cooperation Council (GCC), Japan, Australia, Thailand)
  • South Africa (South Africa)

You can configure your EURSvalidator license according to the country or region you want to file your submission in. You can combine different validation set packages within one license.

Bulk validation set packages are available for submissions in multiple countries and regions:

  • Global (all countries for which validation sets are currently available)
  • EU Unlimited (all EEA (European Economic Area) countries; all EU application procedures)

Besides the purely geographic license packages, the following validation sets are available:

  • Vet Global (veterinary submissions (vNeeS immu/ vNeeS pharma/ vNeeS MRL / VMD-eNTA) for all countries)
  • Best Practice (customized validation sets, e.g. enhanced pdf testing)

Which validation sets do the individual validation set packages contain?

You find a list of the supported validation sets here. 

I am eCTDmanager customer. Does the new licensing model influence validation in eCTDmanager?

Validation per eCTDmanager will not be impacted!

  • eCTDmanager has all validation sets included
  • eCTDmanager users can validate their submissions in eCTDmanager
  • EXTEDO will provide the latest version of validation sets to eCTDmanager customers in the framework of their maintenance contract, so that the validation sets in eCTDmanager can be kept up to date

Validation per stand-alone tool EURSvalidator is with costs and license fees according to the price list apply. 

I am EURS customer. Does the new licensing model influence validation in EURS?

Validation per EURS will not be impacted!

  • EURS has all validation sets included
  • EURS users can validate their submissions in EURS
  • EXTEDO will provide the latest version of validation sets to EURS customers in the framework of their maintenance contract, so that the validation sets in EURS can be kept up to date

Validation per stand-alone tool EURSvalidator is with costs and license fees according to the price list apply. 

What happens to current GLOBALvalidator licenses?

For users who own a license of GLOBALvalidator, please note the following:

  • Current licenses will not be impacted: Your current license will remain in effect as it was and will be supported until the end of the current term
  • All features will remain unchanged until the end of the current license term 

How can I order EURSvalidator licenses? How are the licenses delivered?

You can order licenses using our online store. Upon receipt of your order we will send an invoice, including details on payment, to the billing e-mail address specified in the order form. You can pay by bank transfer, credit card or PayPal. 

Licenses are delivered via a ticket system. Upon receipt of payment we will issue and distribute both the license(s) and setup of EURSvalidator to you. Information and directions on how to collect and activate your EURSvalidator license(s) will be included. 

Which EU application procedure types do the regional validation set packages support?

Procedure types supported (EU applications)

  • "Global" and "EU Unlimited" validation set packages allow validation of submissions for all European application procedures.
  • The regional EU packages allow validation only for MRP (Mutual Recognition Procedure), DCP (Decentralised Procedure) and NP (National Procedure) applications. 

Can I install EURSvalidator on a terminal server?

There is a special license package available for installing EURSvalidator on a terminal server. Please contact info@extedo.com for pricing and further details. 

What happens in case of validation set updates by the regulatory authorities?

All relevant validation sets are included in the respective license package. In case that validation sets in your license package are updated by regulatory authorities during the term of your license, EXTEDO will provide the updated sets free of charge as soon as they become available.  

What happens if I purchase one license package now and another after e.g. three months? Are the terms of the packages synchronized?

No, license terms are not synchronized. You will have different terms for your license packages.  

What happens if I have to exchange the hardware on which EURSvalidator is installed?

If a machine is reinstalled, replaced or a license must be moved from one machine to another please contact finance@extedo.com for further information.  

How about renewal? Are licenses renewed automatically or do I have to re-order them?

Licenses are limited to a term of one year. You will be notified by EURSvalidator prior to the expiry of your license (starting 30 days before expiry date). To renew your license you have to re-order them through our online store.  

What happens if the license file gets lost?

In case your license file gets lost, please contact finance@extedo.com

Best Practise validation set - what is it?

In a Best Practice validation set you can customize your own validation citeria, e.g. enhanced PDF testing. Next to the "EU-PDF BP v1.0 (eCTD v4.1) PDF Best Practice" set additional Best Practice validation sets are available upon request and not included in the EURSvalidator Global license package. Please contact finance@extedo.com for further details.

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