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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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Add SOP removal SOP.
  • Loading branch information
yujanshrestha committed Jan 13, 2021
commit 66e7786efb31dc038fb5415ed97aed2318dcd08b
73 changes: 73 additions & 0 deletions rdm/init_files/documents/quality_manual/SOPs/remove_sop.md
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---
id: SOP Removal SOP
revision: 1
title: SOP Removal SOP
---

# Purpose

This SOP describes how to change existing SOPs.

# Approvals

| Name | Role | Date |
|---|---|---|
| Yujan Shrestha | Quality Systems SME | January 12, 2021

# Change History

| Change Description | Date
| --- | ---
| Initial version | January 12, 2021

# Required Roles to Execute

The following user roles are required to execute this SOP:

- Quality Systems SME
- All roles under "Required Roles to Review" for the SOP to be changed
- All roles under "Required Roles to Execute" for the SOP to be changed

# Required Roles to Review

The following user roles are required for initial approval, periodic review, and change approval of this SOP:

- Quality Systems SME

# Required Inputs and Dependencies

The following inputs are required for the execution of this SOP:

- The SOP to be removed.
- This SOP cannot be removed.

# Outputs

The SOP shall produce the following outputs:

- An SOP removal record.

# Risk Level

Low: Error in SOP or SOP execution is unlikely to result in patient harm.

# Periodic Review

Low: Review once a year.

# Record Template

The record for SOP execution is a new SOP revision and additions to the "Change History" section
in the SOP to be changed.

# Work Instruction

1. Ensure your local quality manual Git repository is up to date. Ensure you are on the `master` branch and perform a `git pull`
1. Create a new branch in the quality manual Git repository.
Give the branch a descriptive name and use snake case such as: `remove_sop/new_complaint_sop`
1. Copy `templates/remove_sop.md` to records and follow the instructions there.
1. Add the newly created record to version control and capture approvals.
1. Delete the SOP file.
1. Commit the changes to Git version control.
1. Create a pull request. Add all approvers.
1. Merge the pull request to `master` once approved.
32 changes: 32 additions & 0 deletions rdm/init_files/documents/quality_manual/templates/remove_sop.md
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---
id: SOP Removal Record Template
revision: 1
title: SOP Removal Record Template
---

# Purpose

This record shall capture the removal of an SOP and the motivations for the removal.

# Approvals

All approvers shall add a signed commit with their name and roles appended to the table in this section.

This approval indicates all authors certify the contents of the record for accuracy and conformance to the SOP.

| Name | Role | Date |
|---|---|---|
| George Costanza | Self Deprecation SME |
| Jerry Seinfeld | Comedy SME |
| Kramer (Cosmo) | Weird Jokes SME |

# Content

## Why was this SOP removed?

## Are there any other SOPs affected by the removal?

## Are there any products that are affected by the removal?

## Are there any additional patient safety risks introduced by the removal of this SOP?

3 changes: 2 additions & 1 deletion tox.ini
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@@ -1,12 +1,13 @@
[tox]
envlist = py35,py36,py37
envlist = py35,py36,py37,py38

[testenv]
extras = test
basepython =
py35: python3.5
py36: python3.6
py37: python3.7
py38: python3.8
deps =
readme_renderer
flake8
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