Purpose
Ensure This work instruction ensures that documents are being managed and maintained appropriately. This work instruction It sets out the steps to enable the Data Science Team to create, maintain, distribute, maintain, and when necessary, deleted archive documents.
Scope
The scope of this work instruction is focused solely on documentation that Data Science uses needs to retain for information purposes and intentionally omits letters, emails, etc.
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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 valid 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. |
VP Data ScienceDepartment 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. |
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Describe each step to be taken to complete the scope of this Work Instruction in the prescribed sequence. Use active verb 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.
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| 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) |
2.1
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| 3.0 | Document Owner | Distribute document only through the approved CDISC systems - Outlook and SharePoint/OneDrive (if it's too large for email)
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| 4 |
| .0 | Document Owner |
Maintain the document to make sure that the content is accurate and |
reliable
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| 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. |
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| 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.
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