CRED Practical Document Writing and Management

Why style and technical requirements are important

What the guidance says: - ● The specification is designed to support high-level functional requirements such as the following: – Copy and paste – Viewing and printing of documents – Annotation of documentation – Facilitate the exporting of information to databases – Searching within and across applications – Navigation throughout the eCTD and its subsequent amendments/variations ● Formats should be readable at least for as long as it is needed for the regulatory process. This process could be very long (e.g. 50 years). This points to the advantage of neutral formats: formal standard, industrial standard, vendor independent, and text- like. The format should be adapted to the type of data. ● The list of agreed formats will be updated as technology evolves and new requirements arise. XML will be the preferred format for all types of data. ● PDF viewing software automatically substitutes a font to display text if the font used to create the text is unavailable on the reviewer’s computer. Font substitution can affect a document’s appearance and structure, and, in some cases, the information conveyed by a document. Agencies cannot guarantee the availability of any fonts except Times New Roman, and Courier and fonts supported in the Acrobat product set itself. All other fonts should be ‘embedded’ to ensure that those fonts would always be available.