Video under Document Control SOP

[invitro_spain]

Hi Folks,

I wonder How I can apply the Document Control SOP and ISO 13485 requirement to a video. The content of this video is the description of our device method of use. So, the video is used for the Customer training.

Any idea will be appreciated. Thanks

 

[ScottK]

Hi Folks,

I wonder How I can apply the Document Control SOP and ISO 13485 requirement to a video. The content of this video is the description of our device method of use. So, the video is used for the Customer training.

Any idea will be appreciated. Thanks

First I would make a provision in the document control procedure that videos can be considered documents and, if so, must be controlled in accordance with the procedure.

I personally would control it just like a work instruction but I would make a provision that the revision level is documented in the file name... like "Training Video 1 Rev A Jan 25 2018.mpg" or something. Use the same change control process as any other document.

I have worked with electronic doc management systems that will also accept video and audio files so it's not an unheard of thing.

 

[invitro_spain]

First I would make a provision in the document control procedure that videos can be considered documents and, if so, must be controlled in accordance with the procedure.

I personally would control it just like a work instruction but I would make a provision that the revision level is documented in the file name... like "Training Video 1 Rev A Jan 25 2018.mpg" or something. Use the same change control process as any other document.

I have worked with electronic doc management systems that will also accept video and audio files so it's not an unheard of thing.

Thank you. Although we have and a hybrid system (paper-based and some electronics records), I suppose that modify the Document Control SOP and upload the video in the document flow (Alfresco in this case) is enough as a evidence.