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| Stage | Description |
|---|---|
| Create | A document needs to be well designed from the point of creation using the name, category, confidentiality classification. |
| Distribute | A document is available for employees and/or the general public according to the confidentiality classification. |
| Use | A document has been distributed internally, and can generate business decisions, further actions, or serve other purposes. (external use is outside the scope of this policy) |
| Maintain | While a document is in active use, it is necessary that the content is maintained, accurate and available. If changes in the document need to be donemade, those changes need to be documented within the document. |
| Dispose / Archive | This will occur with a document that is accessed less frequently or has reached its assigned retention periods. During this stage, the document could be destructed or transfer to a file until an Archive period is reached. |
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- Emails - Internal Emails can just have the title of the subject. External Emails need to have "CDISC" + title
SOPs - SOPs will include numbers at the end of the title according to the Standard, for example, 001, 002
- Work Instructions - Name of the work instruction + "Work Instructions"
- Policies and guidance - Name of the policy + "Policy" + Version
- Meeting papers and minutes - Department + "Meeting" + date
- Education material - Name of the topic + Version
- Reports - Name of the report + Department
- Contracts - Name of the employee or contractor + "Contract" + "Confidential"
- Presentations - Name of the presentation + Department
Retention Stability Category - Retention category is for how long documents stay on CDISC systemStability Category refers to the reliability of a document and if it will need ongoing maintenance.
- Class A - This kind of
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- document will be kept without any
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- modification since it was created for an event in the past. Examples of these
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- documents are meeting papers and minutes.
- Class B - This kind of informational document will have a Stability Period. When the stability period is exhausted, the document will
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- need to be reviewed by the owner
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- to decide if the document is reliable or if it needs an update
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- .
Confidentiality - In order to maintain confidentiality, documents will be designated using one of five classifications:
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- It is used for a process
- It is giving business value to the company
- It is used to back up another document
- It was created to use in the near future
- It was created for a project that hasn´t kicked off
All documents considered not needed must go through a Retention Period before they are deleted. that are no longer required will be archived.
Document Update
When updating a document, the employee or contractor owner of the document needs to make sure of the following points:
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