CRED Practical Document Writing and Management

Dossier Management - Record

Paper and electronic ● Functional areas will be responsible for creating their documents / content within the eDMS. They should also: - – Ensure documents undergo formatting or report publishing activities (including documents from third parties / vendors) – Reports from partnered companies / CROs / vendors are: - – ‘submission ready’ – PDFs are free from security settings – PDF was produced from text source, such as MS Word, but if scanned, copies should be legible and OCR’d ( exclusions apply to original GMP certificate, CoA, manufacturer’s licenses, certificate of suitability, manufacturing Authorisation; document written in a foreign language where a translation is provided in English, literature references sourced from journals, periodicals and books (except when these are used in a bibliographic application to support the main claims of the application), any page with a signature that does not contain other information key to the understanding of the submission ) ● CTD structured folders should already exist in your eDMS or templates should be readily available for use