Add 21.CFR.820 references and training record.

rdm/init_files/organization_qms/SOPs/capa.md

@@ -1,34 +1,39 @@
 ---
-id: CAPA SOP
 revision: 1
 title: CAPA SOP
 ---
 # Approvals
 
 All approvers shall add a signed commit with their name and roles appended to the table in this section.
 
+| Name | Role                | Date |
+| ---- | ------------------- | ---- |
+|      | Quality Systems SME |      |
+
+# Training Record
+
 | Name | Role | Date |
-|---|---|---|
-| Yujan Shrestha | Quality Systems SME | January 14, 2021
+| ---- | ---- | ---- |
+|      |      |      |
 
 # Purpose
 
-This SOP shall describe the process for creating, executing, and concluding a corrective action / preventative action (CAPA).
+This SOP shall describe the process for creating, executing, and concluding a corrective action / preventative action (CAPA).[[21.CFR.820.100]]
 
 # Change History
 
 The change history section shall contain a brief summary of changes made in this revision.
 
-| Change Description | Date
-| --- | ---
-| Initial version | January 12, 2021
+| Change Description | Date |
+| ------------------ | ---- |
+| Initial version    |      |
 
 # Required Roles to Execute
 
 The following user roles are required to execute this SOP:
 
 - Quality Systems SME
-- All roles necessary to execute the CAPA
+- All roles necessary to execute the CAPA 
 
 # Required Roles to Review
 
@@ -55,7 +60,7 @@ High: Error in SOP or SOP execution is likely to result in patient harm.
 
 # Periodic Review
 
-Author shall insert the review periodicity depending on the risk level. For reference:
+Author shall insert the review periodicity depending on the risk level.
 
 High: Review every six months.
 

rdm/init_files/organization_qms/SOPs/change_sop.md

@@ -1,28 +1,35 @@
 ---
-id: SOP Change SOP
 revision: 1
 title: SOP Change SOP
 ---
 
 # Approvals
 
+| Name | Role                | Date |
+| ---- | ------------------- | ---- |
+|      | Quality Systems SME |      |
+
+# Training Record
+
+By signing below you have acknowledged you have read and understood this document.
+
 | Name | Role | Date |
-|---|---|---|
-| Yujan Shrestha | Quality Systems SME | January 12, 2021
+| ---- | ---- | ---- |
+|      |      |      |
 
 # Purpose
 
-This SOP describes how to change existing SOPs. 
+This SOP describes how to change existing SOPs.  [[21.CFR.820.40.b]]
 
 # Triggers
 
 This SOP is usually triggered by an upstream CAPA or through a review of the SOP.
 
 # Change History
 
-| Change Description | Date
-| --- | ---
-| Initial version | January 12, 2021
+| Change Description | Date             |
+| ------------------ | ---------------- |
+| Initial version    | January 20, 2021 |
 
 # Required Roles to Execute
 

rdm/init_files/organization_qms/SOPs/new_product.md

@@ -1,23 +1,30 @@
 ---
-id: SOP Change SOP
 revision: 1
 title: SOP Change SOP
 ---
 # Approvals
 
+| Name | Role                | Date |
+| ---- | ------------------- | ---- |
+|      | Quality Systems SME |      |
+
+# Training Record
+
+By signing below you have acknowledged you have read and understood this document.
+
 | Name | Role | Date |
-|---|---|---|
-| Yujan Shrestha | Quality Systems SME | January 12, 2021
+| ---- | ---- | ---- |
+|      |      |      |
 
 # Purpose
 
 This SOP describes how to add a new product under the quality management system.
 
 # Change History
 
-| Change Description | Date
-| --- | ---
-| Initial version | January 12, 2021
+| Change Description | Date             |
+| ------------------ | ---------------- |
+| Initial version    | January 20, 2021 |
 
 # Required Roles to Execute
 
@@ -42,8 +49,7 @@ The following inputs are required for the execution of this SOP:
 The SOP shall produce the following outputs:
 
 - A product code git repository with RDM installed.
-- A DHF directory in Box.
-- A record 
+- A DHF directory in a file sharing platform. [[21.CFR.820.30.j]]
 
 # Risk Level
 
@@ -66,10 +72,5 @@ in the SOP to be changed.
 1. Make the necessary changes to the SOP.
 1. Commit the changes to Git version control. 
 1. Create a new directory under Box with the name of the product. 
-1. Create a new record 
-
-
-This directory shall contain the outputs of rdm for version 1.0.0 of the product. The contents of this directory shall capture all facets of the design of the medical device including:
-
-This directory typically contains outputs that are submitted to regulatory bodies. A "note to file" or "letter to file" is just another version directory but without submission to regulatory bodies.
+1. Add a new row in `documents/product_registry.md`
 

rdm/init_files/organization_qms/SOPs/new_sop.md

@@ -1,5 +1,4 @@
 ---
-id: SOP Creation SOP
 revision: 1
 title: SOP Creation SOP
 ---
@@ -9,9 +8,17 @@ title: SOP Creation SOP
 |---|---|---|
 | | | |
 
+# Training Record
+
+By signing below you have acknowledged you have read and understood this document.
+
+| Name | Role | Date |
+| ---- | ---- | ---- |
+|      |      |      |
+
 # Purpose
 
-This SOP shall be invoked when a new SOP needs to be created. New SOPs may be created for a variety of reasons such as:
+This SOP shall be invoked when a new SOP needs to be created [[21.CFR.820.20.e]]. New SOPs may be created for a variety of reasons such as:
 
 - Coming into conformance to existing or new regulations
 - A result of a corrective action / preventative action
@@ -58,4 +65,4 @@ A record of execution for this SOP is a new SOP. The template is found in the `t
 1. Fill in each section with relevant content for the new SOP.
 1. Commit the newly added files. Push the files up to GitHub.
 1. In GitHub, create Pull Request for the newly created branch. Add reviewers until all roles listed under the section "Required Roles to Review" have been fulfilled. 
-1. Once all reviewers have been satisfied with the SOP, each reviewer shall add their name to the approvals table.
+1. Once all reviewers have been satisfied with the SOP, each reviewer shall add their name to the approvals table in Github. This creates a signed commit that constitutes an electronic signature. [[21.CFR.820.40.a]]

rdm/init_files/organization_qms/SOPs/new_tool_validation.md

@@ -1,7 +1,6 @@
 ---
-id: New Vendor SOP
 revision: 1
-title: New Vendor SOP
+title: New Tool Validation SOP
 ---
 
 # Approvals
@@ -10,11 +9,19 @@ All approvers shall add a signed commit with their name and roles appended to th
 
 | Name | Role | Date |
 |---|---|---|
-| Yujan Shrestha | Regulatory SME |
+|  | Regulatory SME ||
+
+# Training Record
+
+By signing below you have acknowledged you have read and understood this document.
+
+| Name | Role | Date |
+| ---- | ---- | ---- |
+|      |      |      |
 
 # Purpose
 
-This SOP details the process to validate a new tool for use within the quality management system.
+This SOP details the process to validate a new tool for use within the quality management system. [[21.CFR.820.70.i]]
 
 As a software as a medical device manufacturer, most of our tools will be software. Any tool to be used as part of the
 quality management system shall be validated using this procedure before use.
@@ -27,9 +34,9 @@ This SOP must be executed every time the organization wishes to use a new softwa
 
 The change history section shall contain a brief summary of changes made in this revision.
 
-| Change Description | Date
-| --- | ---
-| Initial version | January 20, 2021
+| Change Description | Date             |
+| ------------------ | ---------------- |
+| Initial version    | January 20, 2021 |
 
 # Required Roles to Execute
 

rdm/init_files/organization_qms/SOPs/new_vendor.md

@@ -1,5 +1,4 @@
 ---
-id: New Vendor SOP
 revision: 1
 title: New Vendor SOP
 ---
@@ -10,13 +9,19 @@ All approvers shall add a signed commit with their name and roles appended to th
 
 | Name | Role | Date |
 |---|---|---|
-| George Costanza | Self Deprecation SME |
-| Jerry Seinfeld | Comedy SME |
-| Kramer (Cosmo) | Weird Jokes SME |
+|      | Quality Systems SME |      |
+
+# Training Record
+
+By signing below you have acknowledged you have read and understood this document.
+
+| Name | Role | Date |
+| ---- | ---- | ---- |
+|      |      |      |
 
 # Purpose
 
-This SOP details the process to qualify a new vendor.
+This SOP details the process to qualify a new vendor. [[21.CFR.820.50.a]]
 
 # Triggers
 
@@ -26,9 +31,9 @@ This SOP must be executed every time the organization wishes to outsource a proc
 
 The change history section shall contain a brief summary of changes made in this revision.
 
-| Change Description | Date
-| --- | ---
-| Initial version | January 12, 2021
+| Change Description | Date             |
+| ------------------ | ---------------- |
+| Initial version    | January 20, 2021 |
 
 # Required Roles to Execute
 

rdm/init_files/organization_qms/SOPs/remove_sop.md

@@ -1,24 +1,31 @@
 ---
-id: SOP Removal SOP
 revision: 1
 title: SOP Removal SOP
 ---
 
 # Approvals
 
 | Name | Role | Date |
-|---|---|---|
-| Yujan Shrestha | Quality Systems SME | January 12, 2021
+| ---- | ---- | ---- |
+|      |      |      |
+
+# Training Record
+
+By signing below you have acknowledged you have read and understood this document.
+
+| Name | Role | Date |
+| ---- | ---- | ---- |
+|      |      |      |
 
 # Purpose
 
-This SOP describes how to change existing SOPs. 
+This SOP describes how to remove existing SOPs. [[21.CFR.820.40.a]]
 
 # Change History
 
-| Change Description | Date
-| --- | ---
-| Initial version | January 12, 2021
+| Change Description | Date             |
+| ------------------ | ---------------- |
+| Initial version    | January 20, 2021 |
 
 # Required Roles to Execute