Documents mentioned in SOP Deployment

Question

The template for SOP Deployment mentions a number of documents under "Relevant other documentation". This list includes:
• Integration Evaluation Checklist (IECL)
• Integration Validation Checklist (IVCL)
• Software Requirement Specifications
• List of Medical Devices (PROD)
• User Training Strategy
• Template User Training Record
• User Consent Form (if applicable)

However, I could not find any templates for these documents (except for the List of Medical Devices). Are there no templates for these documents available or are these aspects included in other documents? Or is it not necessary to have these documents prepared for the compliance assessment?

Dr. Oliver Eidel · Answer

Hey, great question! Going through your list one by one:
• Software Requirement Specifications: Here's the link to the template.
• List of medical devices: Link to template.
• Integration checklists: The idea here is that you create those yourself because it really depends on your company and product what sort of things you want to ensure went "integrating" your software into your clients IT systems (.. if you do that at all). Or maybe you don't do that at all and deploy to a cloud provider like AWS, then you'd probably name those documents differently (Deployment Checklist?), and also include other items in them. You get the idea.
• User training documents: Nowadays, we handle user training documentation in our eQMS software, Formwork. That's why we got "lazy" and didn't create a document-based template for that. So your options here are to either create your own templates or simply use Formwork. I'm obviously hugely biased, but I do think that Formwork is a great tool here because there's a free tier and it saves you a lot of time with your training documentation - you essentially just create a training matrix and, based on that, Formwork generates fancy spreadsheets which you can export as documentation and hand in to your auditors.

Hope it helped. Let me know if you have any further questions!

Documents mentioned in SOP Deployment

1 Answer

Keep reading

ISO 14971 Wrap-Up: Sanity Check, AI Descriptions, Risk Management Plan & Report

SOP Deployment

What Do You Need To Do? Looking At IEC 62304 And Other Docs