Common file format initiatives – an industry model for scientific archiving?

I was delighted to be invited to speak to the recent Scientific Archivists Group (SAG) conference in Edinburgh

The conference covered a range of topics on GxP. Looking at the different focuses when x = Clinical, Manufacturing, Laboratory, Pharma CoVigilance, or Drug Safety, how to develop risk based approach to records management, how to get senior management buy-in to improve RM/​Archiving Service and, how business value is projected from archived material.

I was able to give the conference an update on the efforts of their colleagues engaged in a Common Pharma File Format Initiative” (CPFFI). This is a Tessella coordinated pre-competitive group of 7 global Pharma companies who have concerns about the number and type of unknown file formats in their archive stores/​document/​content/​ILM systems. Many are from Instrument Lab Vendor machine outputs. These potentially constitute a serious risk to their business, — in terms of non-adherence to Regulatory compliance or being able to produce evidence for legal defence. They also constitute an opportunity for mining as the often raw experimental data from, the past to be used in the present. Thanks to the EU APARSEN project which is funding the work.

If you are a Scientific Archivist and you aren’t a member then I can positively point you to the SAG website and future conferences — join and then join in — you and your organisation won’t regret the investment. http://​www​.sagroup​.org​.uk/

Posted by

Jon Tilbury

Chief Innovation Officer

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