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15736d7
Begin adding 13485 checklist.
yujanshrestha Dec 31, 2020
098d391
Add remaining 13485 checklist items.
yujanshrestha Dec 31, 2020
8e1c545
Add 13485 prefix.
yujanshrestha Dec 31, 2020
54d2cb9
Add initial quality manual compliant to IMDRF /SaMD WG/N23 recommenda…
yujanshrestha Jan 13, 2021
e41c87a
Add SOP creation SOP.
yujanshrestha Jan 13, 2021
f6d85e4
Add SOP change SOP.
yujanshrestha Jan 13, 2021
66e7786
Add SOP removal SOP.
yujanshrestha Jan 13, 2021
690a951
Add new record template template.
yujanshrestha Jan 13, 2021
562fe09
Add SOP review SOP.
yujanshrestha Jan 13, 2021
13f716c
Add new vendor SOP and record template.
yujanshrestha Jan 15, 2021
d0428fb
Add CAPA SOP and CAPA record template.
yujanshrestha Jan 15, 2021
89fdb31
Move approvals up to the top.
yujanshrestha Jan 15, 2021
8fd2b55
Add skeleton sections from IMDRF.N23 to the quality manual.
yujanshrestha Jan 15, 2021
f685686
Restructure into separate organization and product quality management…
yujanshrestha Jan 15, 2021
8e2c0c8
Add tools validation process
yujanshrestha Jan 20, 2021
16dd24f
Restructure init templates.
yujanshrestha Jan 28, 2021
71d1c04
Add 21.CFR.820 references.
yujanshrestha Jan 28, 2021
dae161f
Add 21.CFR.820 references and training record.
yujanshrestha Jan 28, 2021
936660f
Add sections to quality manual per 21.CFR.820.
yujanshrestha Jan 28, 2021
920acd9
Add 21.CFR.820 checklist.
yujanshrestha Jan 28, 2021
578da06
Add risk management process.
yujanshrestha Jan 28, 2021
dbee8cf
Change wording of problem report qualification.
yujanshrestha Jan 28, 2021
f2d1797
Reformat whitespace.
yujanshrestha Jan 28, 2021
ab5a5be
Remove IMDRF version of quality manual.
yujanshrestha Jan 28, 2021
9c8356e
Add Audit SOPs and Record templates
yujanshrestha Jan 28, 2021
cddcbab
Add training SOP.
yujanshrestha Feb 2, 2021
b0f1cee
Add templates.
yujanshrestha Mar 9, 2021
ff1325b
Add verification and validation plan.
yujanshrestha Mar 9, 2021
0c957f6
Add risk management process assets.
yujanshrestha Mar 9, 2021
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Restructure into separate organization and product quality management…
… systems.

The idea is the organization QMS will live in its own git repository and the product QMS will live in the same git repository as the codebase.
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yujanshrestha committed Jan 15, 2021
commit f6856867e4a3fd32e82d3ecb9824745cb951cf21
Original file line number Diff line number Diff line change
Expand Up @@ -103,20 +103,20 @@ Use something like: `![Screen One](../images/uimockups/example-ui-mockup-001.png

Which produces:

![Screen One](../images/uimockups/example-ui-mockup-001.png)
![Screen One](../../images/uimockups/example-ui-mockup-001.png)

## Screen Two (SVG)

Use something like: `![Screen Two](../images/uimockups/example-ui-mockup-002.svg)`

Which produces:

![Screen Two](../images/uimockups/example-ui-mockup-002.svg)
![Screen Two](../../images/uimockups/example-ui-mockup-002.svg)

## Screen Three (JPG)

Use something like: `![Screen Three](../images/uimockups/example-ui-mockup-003.jpg)`

Which produces:

![Screen Three](../images/uimockups/example-ui-mockup-003.jpg)
![Screen Three](../../images/uimockups/example-ui-mockup-003.jpg)
Original file line number Diff line number Diff line change
Expand Up @@ -114,10 +114,12 @@ This section of the software plan describes the various activities involved with

## Activity Diagram

![Overview of life-cycle processes](../images/lifecycle-processes.svg)
![Overview of life-cycle processes](../../images/lifecycle-processes.svg)

## Planning

The purpose of the design activity is to define the architecture, components, and interfaces of the software system based on requirements. [[IMDRF.N23:8.2]]

**Input:** System requirements and risk controls

Setup a Git repository on GitHub. All software activity outputs will be stored in this Git repository, the associated GitHub issues, or the associated GitHub pull requests, unless explicitly noted otherwise [[62304:5.1.1.b]]. The software developers working on the project are responsible for keeping all software activity outputs within version control at the times specified in the activity descriptions [[62304:5.1.9.c, 62304:5.1.9.d, and 62304:5.1.9.e]].
Expand Down Expand Up @@ -523,7 +525,7 @@ Writing software requirements is an art and a science; one must find balance bet
{% if not system.is_software_only_device %}
The distinction between system requirements and software requirements can be challenging. System requirements describe the requirements of the entire system, including software and hardware. Software requirements must be traceable to all of the system requirements that they help fulfill. Software requirements are usually more detailed than the system requirements they refer to. Many system requirements will be fulfilled using both hardware and software.
{% endif %}
The distinction between software requirements and the specifications is {% if not system.is_software_only_device %}also {% endif %}typically challenging. Requirements should:
The distinction between software requirements and the specifications is {% if not system.is_software_only_device %}also {% endif %}typically challenging. Requirements should [[IMDRF.N23:8.1]]:

- not imply solution
- be verifiable
Expand Down