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Prince Technologies are announcing that Clarity software supports CFR 21 Part 11

8th January 2013

Prince Technologies are pleased to announce that they have gained accreditation against the US CFR 21 Part 11 standard.

CFR 21 Part 11 is the directive issued by the United States of America Federal Drug Administration agency (FDA). It specifies conditions which must be met when an organization intends to submit or store documents required by the FDA in the form of electronic records, instead in the traditional paper form. The major concerns of this code are related to the nature of electronic records, with respect to their reliability compared to paper form documents.

The major issues are:


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