Product Documents are documents related to each product under registration. Generally product documents involve specific information of the product, or it can be a compiled dossier of many documents. The amount of time that can be spent on a product document will vary greatly depending on the type of document and where it will be from.
Based on the type, there are a few examples of the documents:
• Administrative documents: eg. Application form for a product registration involving information of each product
• Quality Certification/Analysis: eg. FDA 501k certificate for a specific product, COA
• Technical Documents: eg. CTD Dossier for pharmaceutical products, Clinical Study Reports
• Others: In our system, some other requirements that are not documents related to a product are also tracked under PR for functionality. Eg. Packaging Artwork, Samples
Based on the source, there are a few examples of the documents:
• Vendor
• AdvaCare
• Agent
These documents may take a long process from the Vendor/Agent side, and therefore the initial communication between RA Dept. with Vendors is very important to ensure that the process is started on the Vendor’s side as soon as possible. Like Site Documents, RA Dept. normally does not need to be responsible in ensuring the completion of documents but may need to assist BD Salesperson in completing them.