If a company documents its work and data on paper, instead of in computer systems, this is technically compliant with the regulations, but does not meet regulator expectations for a modern operation. FDA would be concerned that a paper-based company, with thousands of records and millions of data points, would not be able to:

Question

If a company documents its work and data on paper, instead of in computer systems, this is technically compliant with the regulations, but does not meet regulator expectations for a modern operation.  FDA would be concerned that a paper-based company, with thousands of records and millions of data points, would not be able to:

Answer

Have enough space on its site to store all the paper

Answer

Know where to find specific data

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Calculate metrics to track

Answer

Search and sort the information to identify trends or shifts in its data that signal a potential product quality or safety concern

Crowdly

If a company documents its work and data on paper, instead of in computer system...

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