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Do you know what 'readily available' means in the context of 21 CFR Part 11 documentation?


Nov 07, 2010 | Free Downloads | email | Print

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If you're familiar with 21 CFR Part 11 documentation you may have wondered what "ready available" means. Or perhaps you've also wondered what "instantly" refers to in the same context. According to Labcompliance News1, it's these phrases that keep regulated companies guessing.

Now, FDA inspectors, after the completion of a 483 inspection, have answered the 'readily available' query by clarifying what it means to NOT have documentation that is readily available.

During this particular inspection, an inspector found that requested documentation was provided but was unorganized. When this occurred, the inspector essentially deemed the documentation not readily available and asked to view the same documentation in a digital format.

What this means is that the organized display of documented information on both hard copies and in digital formats is of the utmost importance for maintaining compliance in any regulated environment.

References

1. FDA Inspection Clarifies what "Readily Available Documentation" Means
http://www.labcompliance.com/news/2010/08_aug_news.aspx#02



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