Purpose

This work instruction ensures that documents are being managed and maintained appropriately. It sets out the steps to enable the Data Science Team to create, maintain, distribute, and when necessary, archive documents.

Scope

The scope of this work instruction is focused solely on documentation that Data Science needs to retain for information purposes and intentionally omits letters, emails, etc.

Prerequisites

This work instruction extends from the Document Management Policy and is dependent on a harmonized system where documentation is created and maintained.

Definitions

List terms (abbreviations, acronyms, technical jargon) referenced in this Work Instruction useful at adding clarity. Put "Not applicable." if this section is not applicable.

Term	Definition
Time To Live (TTL)	This is how long a document is considered to be reliable before it must be reviewed and either confirmed reliable and necessary, updated, or marked for archival.

Roles & Responsibilities

Lists all roles and their responsibilities relevant to this Work Instruction.

Role	Responsibilities
Document Owner	Creates, updates, archives documents based on their usefulness or sends them to legal hold.
Department Head	Responsible for document owner fulfilling responsibilities and assigns replacement document owners as appropriate.
System Administrator	Responsible for systems where documentation is created, maintained, and managed.

Instructions

Describe each step to be taken to complete the scope of this Work Instruction in the prescribed sequence. Use active verbs in the Instructions column.

Step #	Role	Instructions
1.0	Document Owner	Create a document and title it with a name, category, and confidentiality classification. Create a Name by... e.g. Identify a Category by... e.g. Establish the Confidentiality by... e.g. Documents that are created have a default stability period from the date of creation that specifies the minimum time the document is expected to be accurate and reliable.
2.0	Document Owner	Store the document in the appropriate CDISC system used by the Data Science Team (Confluence Wiki, SharePoint / OneDrive, Azure DevOps Wiki, GitHub Wiki) Store documents in SharePoint/OneDrive when they are Policies and Standard Operation Procedures. Store documents in Confluence Wiki when they are used to collaborate and share information with CDISC and CDISC Members. Stoe documents in Azure DevOps Project Wiki that are used for the project and technical artifacts and maybe a draft of published content to GitHub Wiki. Store documents in the GitHub Wiki that are pertinent to Open Source projects' technical artifacts.
3.0	Document Owner	Distribute document only through the approved CDISC systems - Outlook and SharePoint/OneDrive (if it's too large for email) Distribute documentation via MSFT Outlook Email Distribute documentation that is too large for email by placing it in Sharepoint/OneDrive
4.0	Document Owner	Maintain the document to make sure that the content is accurate and reliable Review the document at the end of the stability period and determine if it is still relevant Update the document if it is still needed by the department but needs additional or updated information and reset its stability period Archive the document if it is not needed by the department
5.0	Department Head	Send to Document Owner to update and/or confirm document reliability and add one year to the end of a document's Stability Period or mark for archival. Reestablishes the document to its previous location and owner after two years in Archived Period if he considers that the document could be used again Deletes the document after two years in Archived Period if is not needed anymore
6.0	Department Head	Provide a valid document owner when a document owner leaves the department or company

General Workflow

Include a general workflow diagram that summarizes this Work Instruction.

Document Management Work Instructions

References

List references pertinent to this Work Instruction, e.g., COP-001.

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Document Management Policy Work Instruction