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QMS documents required at each stage of Software development

#1
Hello all,

I am a new QMS engineer and seeking some guidance. I am looking for a diagram or a process flow on what document are required at what stage of release cycle? Like kick off, Development, testing, release etc? I found some checklists online but am looking for something more visual.
I understand the documents will\may be different for each company but I am looking for something as my starting base..

Thanks...
 

yodon

Staff member
Super Moderator
#2
It's a tough question to give a straight answer on due to a variety of reasons.

First, documentation requirements are driven by the software safety class.

Second, software development is typically iterative so completion of the deliverables end up on the back-end of the process. The Plan should be created / stabilized pretty early on and you should be able to get some level of stability on requirements, but architecture & design docs are typically updated as development progresses. This is difficult to show in a flowchart, which is often construed as a 'waterfall' approach.

Do a search for 'software v model' - that's generally a good representation of the process / outputs - just realize that there's typically a lot of iteration in the middle (and maybe extending outwards depending on how agile the process is).
 
#3
It's a tough question to give a straight answer on due to a variety of reasons.

First, documentation requirements are driven by the software safety class.

Second, software development is typically iterative so completion of the deliverables end up on the back-end of the process. The Plan should be created / stabilized pretty early on and you should be able to get some level of stability on requirements, but architecture & design docs are typically updated as development progresses. This is difficult to show in a flowchart, which is often construed as a 'waterfall' approach.

Do a search for 'software v model' - that's generally a good representation of the process / outputs - just realize that there's typically a lot of iteration in the middle (and maybe extending outwards depending on how agile the process is).

Thanks.. I was actually looking for a basic medical software process and what point of release the team is filling or thinking about which QMS document .. something i can show the team during their QMS training
 
#5
Hi, not sure I fully understand what's underlying your questions. I will try and address specific elements of your last articulation, assuming you are referring to US regulatory requirements.

- basic medical software process This would be the basic Design Controls specified under 21 CFR 820.30 ( IEC 62304 is loosely aligned with FDA's requirements). Each company must articulate their process and align said process with the requirements called out under 820.30 and 62304 (Nice find, Yodon!). If the product is sold internationally, the process must also meet the requirements of ISO 13485:2016.
- which QMS documents are needed for release That is what must be specified from understanding and applying the regulation and standard mentioned above
It is important to know the content of the recent SaMD rules see www for fda.gov/medical-devices/digital-health/software-medical-device-samd

I am curious who is delivering your QMS training. since their qualifications are subject to review during FDA inspection/NB audit.

Please let me know if you have more questions.
Christine
 
#6
Hello all,

I am a new QMS engineer and seeking some guidance. I am looking for a diagram or a process flow on what document are required at what stage of release cycle? Like kick off, Development, testing, release etc? I found some checklists online but am looking for something more visual.
I understand the documents will\may be different for each company but I am looking for something as my starting base..

Thanks...
1561587221594.png


Hello IGO...Here is an oversimplified SDLC to Documentation mapping for a traditional form of SW Development
 
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