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Frequently Asked Questions

1) Is your software an independent solution or do customers need to have other software installed in order to use it?

Our Centrality software solution is completely independent – no other software needs to be installed. The software can run on a standalone machine or on a network. We offer full support for both Windows and Linux.  For our complete product brochure and full list of features and benefits, please see here.

2) Do you offer Software-as-a-Service and/or on-site installation?

We offer fully flexible deployment options. The Centrality platform is available as an on-demand cloud-based application (Software-as-a-Service) accessed via a standard web browser, or as a standalone software application.  For clients who wish to have all their data in-house we offer on-site installs. Centrality can be installed on your company intranet, so that the data is held on-site and authorised users can access it securely via the company system. We offer transparent pricing for all service package options.

3) What assurances can you provide about the security of your Data Centre?

Our data centre is EU-based and it is compliant and fully up-to-date with the appropriate Data Protection Act legislation. We use a dedicated redundant server network located in a secure underground location.  We are happy to meet any documentation and certification requirements that you may have.

4) Does your software offer integration capabilities with other software packages (for example, SAP, Documentum, TrackWise)?

We import and export XML and CSV files, enabling total ease of integration with all existing enterprise and pharmaceutical regulatory software platforms. We can build custom interfaces to any other software suites as needed, based on the availability of a documented API giving access to the required data.

5) What guarantees do you have that your offering meets the EMA requirements?

Our software is generated directly from the schemas issued by the EMA. All database elements as well as the XML output are directly driven from these officially mandated schema, producing valid, syntactically-correct XML.  With regard to the business rules which form part of the EMA requirements, where automation is possible, we have also implemented syntax checking to ensure that the XML output and field syntax is correct.  There are certain business rules within the requirements that are close to impossible to check automatically, and which will require human interpretation and qualification. We provide a full range of support and consulting services to help with this and all other issues related to EVMPD implementation.

6) How future-proof is the Centrality solution?  How will you support the ongoing changes to the EMA’s e-submission requirements?

Since our software is directly generated from the schemas, we are able – and can prove – that we can re-generate all the database structures and form logic within 24 hours. Our stringent testing and QA procedures will mean that we are confident of releasing a new version of our platform within 7 days of any new schema publication.  In terms of migration to the planned ISO IDMP standard – and indeed any intermediate schemes – the schema-derived nature of our platform means that any specification changes can be seamlessly and quickly incorporated into our platform.  Our solution is specifically designed to provide an ongoing product data e-reporting solution and fully centralised product information database for future use.  Centrality provides integrated, intuitive capabilities for managing ongoing updates to product data – for EVMPD and beyond.

Centrality software

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We have also made available an excel spreadsheet for data entry. If you prefer to enter your data in excel, then use this spreadsheet and we will be able to import, check and convert the data to compliant XML.

Download excel