It is critical that Life Sciences companies establish, document, and control their processes for authoring electronic documents, scanning paper documents, and handling each document type (e.g. CSR, Protocol, Summary, etc.) for each type of dossier (e.g. IND, NDA, BLA, PMA, eCTD, etc.).
Each type of document will present its own challenges to regulatory publishing. All documents to be authored for a dossier should be started with a template that includes agreed upon standards. Legacy documents should be scanned in, cleaned up, bookmarked and linked; headers and footers should be masked where appropriate. Standards and quality at the beginning of the document lifecycle lead to a more consistent and reliable dossier.
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