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This document describes the functionality for SPORIFY. The Quality Management System GSP states that the Functional Specification (FS) is a description of the product to be supplied in terms of the functions it will perform and the facilities required to meet the user requirements as defined in the Product Release Plan.
This document may be part of the quotation specification and the release deliverables, although it shall not be used as the specification against which the system will be tested. Note that the FS is not a User Guide but a reference document for validation purposes. The FS does not contain design-specific items (e.g. button colors). By default, requirements describing performance related needs, limits and stress behaviours are not part of the FS because they do not describe relevant functional features. However, those requirements are taken into account by the Acceptance Test. In a Performance Qualification (PQ) process for system validation, customers may decide to include them in the test suites (as well as additional, customer-specific Test Cases).
To get the Test Script for a Functional Specification item, refer to the FS identification code (FS - XXXXXXX - Feature Name) in the middle each specification item.
SPORIFY is a purpose built solution to match and manage SPOR controlled vocabularies. Our system provides users with a simplified and centralised method to control the data they require for IDMP from the EMA SPOR master data services. Our intuitive user interface helps to manage company terms and match them with externally hosted controlled vocabularies for the following data domains: SPOR Referentials and Organisations, and G-SRS and EUTCT Substances. SPORIFY matches, maintains, synchronises and integrates SPOR data with local terms, saving users up to 75% of time and effort on initial matching and automatically maintaining the data as SPOR updates into the future with automated updates and alerts. Our out-of-the-box Follow Favourites and Notification services alert users to relevant data changes for data they are interested in. There is no need to manually monitor changing terms because we let you know when something you are interested in changes.
The SPORIFY service acts as a data broker between your internal source system data and externally managed regulatory data such as EMA SPOR and G-SRS. Your source terminologies are imported to SPORIFY, where they are automatically or manually matched to the relevant target system data. SPORIFY monitors data changes on target systems and notifies you of changes relevant to you. All matched data is available for export via Excel or API.