Validation of Spectrometry Software

The author continues his discussion of the principles involved in the backup and recovery of electronic records. This installment looks at the written procedures associated with this process for a spectrometer operating in a regulated laboratory Although this column discusses regulatory requirements and issues, it is important not to forget that the main reason for backing up your application and data is a business one. You'll install your software and then configure the system by defining items such as authorised users, user types, access control privileges, user-defined macros, libraries, and so forth. Imagine the problem if your computer hard disk fails and you have no effective backup.

What happens next? You'll have to reinstall the base software from CD and then input all of the configuration data manually — assuming that you remember what each one was. Not a pleasant thought, is it? Furthermore, consider the data and electronic records that you have created since the original installation — how are you going to recreate these? The simple answer is that without backup records you cannot. Therefore, regardless of the regulations — if you are working in research, development or production — you need an effective backup procedure for business reasons alone. Not convinced yet? Take the example where a spectroscopy laboratory only works with paper. If a regulatory submission is needed and there are spectrometry data to be included you'll have to scan the paper into a format that can be included into the electronic regulatory submission.

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