The challenge of ensuring the long-term accessibility, reliability and authenticity of archived electronic records has been with us for some time, particularly in an industry where retention times can be in excess of 15 years…. sometimes for the marketed life of a drug or device product. There are various strategies to help overcome the problems of software, hardware and operating system obsolescence as well as media failure. However, this task is made even more difficult in an industry that uses so many proprietary file formats. In comparison, the retention of Microsoft office documents is child’s play!
Help could be on its way with the initiation of a Pharmaceutical Common File Format industry group, championed by digital preservation specialists Tessella. The group, currently with six companies represented, intends to explore the challenges involved in the identification and characterization of pharmaceutical-specific file formats. These are formats which are currently not dealt with particularly well by tools such as DROID. Identification and characterization is the first step to developing a strategy for preserving these formats, either by monitoring the availability of software to access the content or by migrating the content to a compatible, more stable file format.
Feel free to contact Tessella directly to get involved. The wider participation there is in this initiative, the more likely it is that the deliverables will be representative of the industry and will be of value.