CRED Practical Document Writing and Management

Dealing with historical documents

Paper to eCTD in practice: - ● High quality electronic source documents, but good quality scanned images would also be acceptable in these cases, preferably with Optical Character Recognition (OCR) to facilitate text searching – Take time to scan, as a sloppy and rushed scan can hinder the OCR performed; and certain words and special characters will not be recognised – A QC should take place to compare the scanned OCR copy and the original paper – Resolution of 300 dots per inch (dpi) to balance legibility and file size – The use of grayscale or colour is discouraged because of file size – After scanning, resampling to a lower resolution should be avoided. ● For baseline submissions, navigation does not need to be reset, as will not be re- checked by agencies ● Must comply with current eCTD specification (v3.2.2) & regional M1 specification