Webinar - Complaint Handling - Best Practices
Answered by- David Lim
The recommendation is that the Day Zero is the day that you received the Complaint by fax or by email and then you record the day. it seems the call center (software application) has a time stamp for each and every call. So basically, when FDA investigators are looking at your documenting system, all you have to do is just describe the system that you have. Every time you receive a phone call, fax or web email and mail and we record as part of our complaint documentation system and then it is logged in and this is the list of logs with the date and time stamped. So describe how you do that, that should be enough.