OASIS eTMF Interoperability Committee Discusses Digital Signatures

oasisThe latest meeting of the OASIS eTMF Interoperability Technical Committee convened yesterday (3rd March). The main topic on the agenda was signatures and how these should be exported from one system to another. A number of interesting Рand perhaps controversial Рissues were discussed. The meeting began with an overview presentation of some of the regulations pertaining to electronic and digital signatures, one of the key ones highlighted being 21CFR11. The guidance from the FDA suggests that export of records should be in common file formats such as PDF, XML or SGML. The benefits of digital signatures was highlighted by Peter Alterman from SAFE-BioPharma.
We pointed out that whilst digital signatures might be seen as “the gold standard”, 21CFR11, the FDA and EMA all permit the use of simple electronic signatures and these are widely used across industry within eTMF systems currently. It is important therefore that any eTMF interoparbility standard should not exclude this type of signature manifestation. Similarly, the discussion focussed heavily on the EMA and FDA requirements for digital signatures on documents included in submissions but these only make up a small part of TMF component (typically 45 artfacts out of the 245 in the TMF Reference Model).
There was even a question raised regarding what documents needed to be signed. It is clear this is outside the remit of the OASIS Technical Committee! It is for industry to decide what documents to sign – referring to relevant regulations – and to use whatever technology is appropriate to them. The OASIS TC then needs to ensure the standard accommodates common industry practice. In fact, the Committee did recognise that wet-ink signatures are still used widely across industry and the metadata model for interoperability needs to recognise the fact that some scanned images in eTMF systems will bear a wet-ink signature and the related file attributes are important for interoperabilty and data exchange.
On the topic of export format for documents, perhaps the Technical Committee is going ‘off piste’ again? The reference to the FDA guidelines is not referring to export of TMF content from one systen to another. The reference actually relates to the provision of TMF content for inspection purposes. Ideally, the original TMF content would be provided but the guidance note 3.4 from the FDA confirms that export of content using automated means to common file formats such as PDF, XML and SGML is permitted. Surely, when transferring TMF content from one eTMF system to another (i.e. TMF interoperability) the ideal scenario is to retain content in its original format? So if the the source eTMF system creates and maintains records in Microsoft Word, the target eTMF system would accept the content in Microsoft Word, and not in a different file format. This is not to preclude file format conversion but simply to state that an interoperability standard should not dictate the source or target file format.
If you have a view on this topic, or any other topic related to TMF interoperability, please make sure you sign up as an OASIS member and join the Technical Committee.

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