Q: I took your course on FDA Auditing of Computerized Systems and Part 11/Annex 11 last year and often refer back to the material when solving compliance questions. But here’s a new one: many companies are now using Facebook, Twitter, YouTube and other social media outlets. From a software validation perspective, are there any FDA expectations for such tools? If so, what’s a company required to do to control and validate these tools?
A: FDA has issued some draft guidance and held a public hearing about the use of social media, but at this point the Agency has been focused exclusively on the control of advertising and promotion.
So first you need to determine what you’re using the social media for. If used only as a means to promote or explain your product and its use — then it’s a promotion and labeling issue, and FDA is more concerned with the appropriateness and accuracy of your posts than it is with validation.
It’s important to determine whether the social media site allows uncontrolled feedback about your product by users, leading to possible off-label promotion.
But it’s also important to determine whether the social media site allows uncontrolled feedback about your product by users, leading to possible off-label promotion. If you post on sites such as Facebook and Twitter, you as the manufacturer are responsible for the post and any related posts, feedback, or comments that are not part of the product’s approved use. You need to explain this fact to those who visit the site or follow the posts. This requirement also applies to links to other sites and posts that may purposely or inadvertently promote your product for an off-label use.
Here’s the gray area still to be addressed: if your social media tool allows users to provide feedback about your product, then it also becomes a possible source of complaints. As such, it may need to be validated for that use — as well as be monitored as an external source of data for your CAPA system. Posts from product users also may indicate an adverse event has occurred.
You need to monitor your social media sites frequently for these purposes, even if FDA has not yet explicitly addressed the role of social media in your quality system.
Answered by Denise Dion, EduQuest VP of Regulatory and Quality Services (18 years as an FDA investigator). Denise is the co-instructor of EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 Compliance training class.