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The ERG also serves as a ready-made teaching tool at graduate and undergraduate levels. Your continued access to and use of the software constitutes your Agreement to be bound by, and your acceptance of, the terms and conditions posted at such time. You acknowledge and agree that you accept this Agreement each time you load, access, or use the software. Third party software and data ("Third-Party Software") may be attached to the Software. Computers As an outgrowth of its current good manufacturing practice initiative for human and animal drugs and biologics,4 FDA is re-examining part 11 as it applies to all FDA regulated products. We anticipate initiating rulemaking to change part 11 as a result of that re-examination. While the re-examination of part 11 is under way, we intend to exercise enforcement discretion with respect to certain part 11 requirements. That is, we do not intend to take enforcement action to enforce compliance with the validation, audit trail, record