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eCTD

The challenge

The electronic Common Technical Document (eCTD) is defined as an electronic interface between industry and agency to transfer regulatory information including directory structure, content/documents and the XML eCTD instance data. In simple terms it is the CTD structure plus regional information in Module 1 in electronic format. Compared to NeeS, the eCTD supports the business process for full submission life cycle, electronic meta data, and extended security, thereby allowing to maximise reusability of information already submitted. Documents should be submitted once and only once.

The eCTD has the advantage of being protected by multiple MD5 checksums, which can be seen as digital finger prints on the application.  The MD5 is widely used as cryptographic hash function, producing a checksum with a 32 digit hexadecimal number, the “fingerprint” or “message digest”. Each document has its own checksum in the XML backbone, which itself is protected by a further checksum. Using this method ensures data integrity in the eCTD.

The solution

Samarind RMS makes the eCTD compilation quick and easy. Following the Emerging Dossier Concept, pre-entered information about the product, its manufacturer, type of licence and more will be reused to create appropriate sections in the eCTD structure as well as the envelope. The need to re-enter information is taken away, thereby minimising data entry mistakes and speeding up the submission review process significantly.

Using the EDMS functionality of Samarind RMS brings further advantages to our users as documents can be allocated on appropriate levels. This speeds up the document selection process during dossier compilation via minimising document availability, and improves dossier quality and consistency for later review via the use of pre-allocated documents.

The benefits

Creating and managing eCTDs with Samarind RMS could not be easier and comes with many benefits.

  • Secure storage for all documents in an easy-to-manage, quick-to-learn environment
  • Ability to allocate documents to products, submissions or licences, simplifying dossier compilation
  • Readymade templates allowing authors to concentrate on content rather than format
  • Automated PDF renditioning, without the need for additional software, ensuring (technical) consistency throughout the dossier to assist submission review and assessment
  • Simple eCTD structure creation reaping the benefit of the Emerging Dossier Concept
  • Automated creation of XML backbone and MD5 checksums, supporting all technical aspects of the eCTD.

Creating the final eCTD output including XML backbone and associated technical files is simple and fast as all documents are stored in the same repository.

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