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New or experienced, this would be a questions any TMF professional might have as they initially address a new project.
I support Eldin’s earlier response, where and how you can minimize your risk and maximize your efficiencies, it is important to do so – and digital solutions can help you do this. However, if you are embracing new or unique tactics, think about what you and your company must have to support those changes.
1. If you go with a digital solution, you need to assure it meets 21 CFR Part 11 requirements, or specific regulatory requirements of the jurisdiction in which you operate.
2. If you convert to a hybrid eTMF/pTMF model, you should modify your TMF Plan to note these changes, and also manage the record of source system on your specifications/index for your TMF.
To your first question, which I don’t think it was directly addressed, if you do not have language in processes or plans to support digital filing, then yes, you will need to print out each email (with attachments) to file in the paper TMF, which should be in keeping with your TMF Plan – always confirm against that document.
In essence, you can manage your TMFs in just about any which way but loose, but you must be certain that your firm’s SOP and/or Plan language supports the methods employed. If it doesn’t yet, but your team is amenable to alternative methods – change your plan first, and then use the new process.
I hope this helps.