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Documents will have an explicit name, retention category, and confidentiality.
Name - The name of the document will be different according to the kind. Here are some examples:
- 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 Category Category -Retention category is for how long documents stay oon CDISC system.
Class A - This kind of documents will be kept without any modifications and for as long as the department exists as these kinds of documents do not need an update for the reason that they were just created to resume an event in the past. Examples of these kinds of documents are meeting papers and minutes.
Class B - This kind of document will be revised every year and the owner will decided if the document needs and update or it is not needed anymore. The Archived Period section talks about a document not needed anymore.
Confidentiality - In order to maintain confidentiality, documents will be designated using one of five classifications:
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After the document is created, it will be available on the CDISC system, and according to its kind, it will be stored and/or distributed
- Outlook - Internal and external Emails must be distributed through official company Email.
- Confluence Wiki - ???
- SharePoint / OneDrive - ???
- Azure DevOps Wiki - Documents related to projects worked on Azure DevOps. Each Document needs to be stored within the project that it is related to.
- GitHub Wiki - ???
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)
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- Documents must include name, date of creation, version, date of the last update (if applicable), date of next review, 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 made.
- When an employee leaves the company, all the 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 transferred to a file until a retention period is reached.
- Documents can’t have a copy in a different location.
- If there are two or more duplicate documents and one is an update of the previous ones, the most recent update is the want that will stay on file, and the others, after a revision, will go to the Retention Period.
- owner
- last modified
- Next review
- status
Dispose
Before any document could be disposed, it needs to be sent to a Retention Period where the document will follow some steps before is deleted.
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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.
- Ensures document is revised whenever a change is required
- At end of the Stability Period, ensures that the document is fit for purpose for another period
- If the document is no longer required marks it as archived
- If the document is auto-archived by the system due to no updates at end of the retention period, reviews the archive report to ensure
- Sends documents to Archived Period when he/she considers necessary.
- Decides if a document needs to be deleted or stay one more year after the year in the Archived Period.
- Decides if a document needs to be deleted or reestablish to its previous location after 2 years in the Archived Period.