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

Answer

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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