21 CFR Part 11 and Good Documentation Practices in Pharmaceutical Industries
<p>It has been said that in the pharmaceutical industry, <em>“If it isn’t documented, it didn’t happen.”</em></p>
<p>Documentation control is not optional; it is a legal requirement. For this reason, good documentation practices–commonly referred to as GDPs–are critical.<br />
Records and reports, along with procedures, “tell the story” of manufactured products and devices. Those working in the pharmaceutical and other healthcare sectors must have “good” documentation practices to ensure the integrity and reliability of data.</p>
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