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All documents created in the company will follow an estatblished established Lifecycle.
| 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 is |
| reached. |
Create
Only CDISC systems will be used to create and/or store and/or distribute CDISC documents:
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All documents must have a Document Revision every year. The first year is mark first-year marks 12 months after the creation and approval, if necessary, of the document.
The purpose of this revision is to make sure that the document is update updated and still needed for the company. Documents that are being use used on a daily basis are considered needed and just need to go through the update. Documents that are not used frequently or haven´t been used during the year must be checked to see if they are still needed. For the document to still be needed, it has to have at least one of the followingsfollowing:
- 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.
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- If there are links in the document, those links need to open working pages. Any dysfunctional link needs to be fixfixed.
- When there are name names of employees addressing a position within the company, specific project or similar, the names need to be update updated to the employee or contractor holding those positions.
- All processes and work instructions must be check to make sure that they are update updated and hadn´t chance. Any small step in the process or work instruction that is different from the document to real-life needs to be updateupdated.
Retention Period
Documents will stay in Retention Period for one-year to for one year to make sure they are not needed again. After one year in Retention Period, the head of the department that department, for which the document is use will used will take another look to at the document and decide if it is time to delete the document or give a one-year extension.
Any document that hadn´t been deleted after the first year in Retention Period will be revise revised again after one more year for the head of the department that , for which the document is use used and decided if it needs to be deleted or needs to be reestablish reestablished to its previous location before Retention Period.
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- Documents must include name, data date of creation, version, date of the last update (if applicable) and , and name of the employee or contractor in charge of the document.
- The employee or contractor who created the document will own it and must make sure that is review every year to check if there are updates that need to be make.
- When an employee leaves the company, all the document documents that he or she owns will be reviewed to make sure that they are still needed. The documents that are still needed for the company will be assigned to a new employee, who from this moment, is taking responsibility for the new documents. Documents that are not needed anymore will be transfer transferred to a file until a retention period is reachreached.
- Documents can’t have a copy on in a different location.
- If there are two or more duplicate documents and one is and an update of the previous ones, the most recent update is the want that will stay on file and file, and the others, after a revision, will go to the Retention Period.
- owner
- last modified
- Next review
- status
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