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Make certain e-data is open up only to those who are allowed to see it. AssurX can make it very easy to “lock out†individuals who aren’t approved to view any e-facts industry that requires shielding.
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Crafted to be certain FDA compliance, the software incorporates Full Article audit trails and Digital signatures compliant to 21 CFR Part 11 and maintains an straightforward to access, protected time-stamped archive.
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Though it may be remote chance, the FDA can even now decide on to examine your subcontractor If you don't have the right supplier controls founded.