CRED Practical Document Writing and Management

Dossier Management - Archive

Paper ● Stored fire proof archive room – Located at head office? ● Stored offsite with a storage company ● To be kept for the duration of the product lifecycle

CD / DVD ● Possible storage in fire proof archive room or offsite ● Internal records management function may refuse to keep CD/DVDs for archive as only have an expiration date of 7 years

electronic ● Second drive with limited user access. Link to an eCTD viewing tool ● Original zip file kept in secured drive & eDMS ● Specific fonts & compatible used a/p ICH guidelines to enable preservation in archive ● Some agencies use unique identification (UUID) to help enable the archiving of the sequence to the correct dossier

BP recommendations: - Use PDF 1.4 or have archival PDF/A contained in submission, no Javascript, 3D dynamic content (audio, video), maximum file size 100MB, use standard fonts addressed in ISO 32000-1: Times New Roman , Helvetica, Courier, Symbol

The eCTD is defined as an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission