Purpose
Ensure that documents are being managed and maintained appropriately. This work instruction sets out the steps to enable the Data Science Team to create, distribute, maintain, and when necessary, deleted documents.
Scope
Prerequisites
This work instruction needs the Document Management Policy and a system where documentation is created, maintained, and managed.
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 |
|---|---|
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 Science | 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 verb in the Instructions column.
| Step # | Role | Instructions |
|---|---|---|
| 1.0 | Document Owner | Creates a document using the name, category, confidentiality classification |
| 2.0 | Document Owner | Distributes or Stores the document through the CDISC system used by the Data Science Team (Confluence Wiki, SharePoint / OneDrive, Azure DevOps Wiki, GitHub Wiki) |
| 3.0 | Document Owner | Maintains the document to make sure that the content is accurate and available |
| 3.1 | Document Owner | Reviews the document after one year of its creation |
| 3.2 | Document Owner | Updates the document if it is still needed for the department but needs added information |
| 3.3 | Document Owner | Sends the document to Archived Period if is not needed for the department after the one year review |
| 4.0 | VP Data Science | Decides if it is time to delete the document from Archived Period or give a one-year extension |
| 4.1 | VP Data Science | 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 |
| 4.2 | VP Data Science | Deletes the document after two years in Archived Period if is not needed anymore |
General Workflow
Include a general workflow diagram that summarizes this Work Instruction.
References
List references pertinent to this Work Instruction, e.g., COP-001.