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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 done, 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 a retention period until an Archive period is reached. |
Create
Only CDISC systems will be used to create and/or store and/or distribute CDISC documents:
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The document will be used meanwhile is active on the CDISC system, and for this purpose, it will be updated and maintain according to the next part of the Lifecycle. Documents need to be stored on the CDISC System to consider them official for the purpose of this policy.
Maintain
Document retention category
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Document revision
Each document must go through a revision to be sure that the document is updated and/or on use. The employee or contractor owner of the document is responsible for this revision.
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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.
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Before any document could be disposed, it needs to be sent to a Retention an Archived Period where the document will follow some steps before is deleted.
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Any document that hadn´t been deleted after the first year in Archived Period will be revised again after one more year for the head of the department, for which the document is used and decided if it needs to be deleted or needs to be reestablished to its previous location before Retention Archived Period.
Any document can´t stay in Archived period for more than two years to avoid using this location as a Recycle bin or a second location for documents that employees or contractors don´t want to take care of.
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