Historically, instructional videos for pharma- ceutical products have been available on YouTube, for example. But, in order to improve patient safety and meet EU & FDA legislation, many life science companies wish to tie the instructional video even closer to the product and to the company. The simple answer is to introduce a QR code featuring a URL to the video in the packaging material and run the video via a dedicated streaming platform. However, once the QR code and link is included in the packaging material, the video becomes ancillary to labelling and must, therefore, fulfil regulatory requirements. Then, you suddenly have a GxP scenario.
Seeing a visual explanation is often stronger and more easily understood than reading the same explanation. And, with the widespread adoption of mobile devices and pc’s, the concept of letting instructional videos support the patient is clear- cut and is embraced by the industry. But there is more to it than rolling cameras and QR codes. It is a classic tale of the true size of the iceberg – with the video being only the bit at the very top. Underneath it is a massive formation of business processes, SOPs and infrastructure that has to be organised.
By including a QR code and link in the packaging material, the video becomes ancillary to label- ling and must therefore fulfil regulatory require- ments. This is similar to the handling of labelling text and introduces two overall actions:
When we unfold these two actions, the life science company must concern itself with the following:
SOPs and guidelines must be written and updated to accommodate regulatory requirements.
Instructional videos must be version-controlled and should be managed by a content manage- ment system to ensure that the instructional video is delivered successfully to the intended individual (patient or HCP). This includes delivering the instructional video in the correct format and language, and taking into considera- tion that various versions might be needed to accommodate for cultural differences and marketed versions of the product.
It is the life science company’s obligation to ensure that the video is available for all customers with a supported device. What infrastructure has to be established to support video on computers and mobile devices, such as smartphones and tablets? As the system is GxP critical, the life science company must also ensure that the infrastructure providing the platform for video streaming is documented in accordance with the requirements and is running 24/7. Naturally, it is outside the control of the life science company to ensure the con- nectivity between the customer and the server. Finally, infrastructure must be updated continuously.
NNIT can facilitate the entire process: define and implement business processes, project manage- ment, validation support, video preparations and global video streaming. We have experience from a full scale project, recently completed, for a large international life sciences company. Our consultants have extensive knowledge about life sciences processes and instruction for use (IFU) requirements, including those defined by the FDA and EMA. And finally, via a partnership, NNIT can provide the platform for video streaming, allowing the customer to focus on the video’s contents.