Document quality control emerges as a discipline in its own right

Document Quality Control Emerges as a Discipline in its Own Right

This white paper is part of DIA’s White Paper Library

Compiling a quality regulatory submission is a basic requirement for biopharmaceutical companies. Poor quality documents could lead to rejection of a regulatory application, requiring significant rework and delays to regulatory decisions. What do we mean by quality in regulatory documentation? Fundamentally, the conclusions drawn from the source data must be robust, but references to source data must also be accurate, and the documents must be free of formatting errors. Investment in a thorough and efficient approach to document QC focused on accuracy, consistency, and style is a “must have” for biopharmaceutical companies.

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