FDA Compliance Seminar on Access Data Base Validation in Drug Discovery

This was worth nothing and the seminar is coming up in January.  Good old Access still the work horse of a lot of data base work.  Actually sometimes with SQL server you may find some front end Access Data Bases combined with SQL to do the work that you can’t program in SQL, they are still out there. 

This seminar is about how to satisfy the FDA requirements in the discipline of Drug Discovery and will go over common technical issues with using Access and how to resolve with submitting data to the FDA.  I am guessing this relates to data on the web that is submitted.  Anyway this was worth the mention here for those who might have an interest with validation and security with MS Access and the FDA requirements.  I still dig out Access here and there to create some quick and dirty SQL statements, easier done in Access than from scratch by all means and I can dump some code modules in to Outlook easily enough this way if needed.  BD

FDA expressly regulates databases and FDA inspectors are specifically trained to look for and at databases. Though database use is widespread throughout most organizations, most organizations lack a clear compliance strategy for 'small' databases.

Many companies struggle with Access database compliance. Some are still using unvalidated databases. Hence an unplanned 'emergency' Access database validation project could paralyze the organization. Many companies lack an understanding of how to satisfy FDA technical validation requirements as applied to Access.

http://www.nature.com/natureevents/science/events/12701-Validation_and_use_of_Access_Databases_in_FDA_regulated_environments

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