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Are all cleanroom records required to be maintained in electronic format?
While paper-based records are not expressly disallowed, the Government Paper Reduction Act (GPEA, Pub.L. 105–277 Title XVII) states that, effective in 2003, federal agencies–including the FDA–must enable the public to utilize electronic documentation in governmental communications, whenever practicable. Therefore, submissions to the FDA are allowed and encouraged to be in an electronic format.
Where cleanrooms are concerned, the intent is to ensure accurate data collection and prevent accidental corruption, loss, or intentional fraud over the lifetime of the dataset. Electronic SOPs and automatic data storage (either onsite or offsite) can help to minimize the risk of post-acquisition manipulation of the data.
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