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IV Pan American Conference on Drug Regulatory Harmonization Dominican Republic March 2 – 4, ... - page 7 / 15

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Chapter 8: Documentation

General Aspects

Carefully designed, prepared and reviewed

Approval of documentation, with signature and date

Proper distribution of documentation

Data may be recorded by electronic data-processing system or photographic means

System for regular revision and updates

Completion during the process

Alterations made should be signed and dated

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