Purpose of this policy
The purpose of this policy is to make sure that documents are being managed and maintained appropriately. This policy sets out standards to enable employees and contractors to create documents that enable the content of all digital and hard copy documents to be accessed, used, and reused in a controlled and efficient manner.
Scope
This policy applies to all digital and hard copies of every document created by any member of CDISC and stored by the company, including but not limited to:
- Letters (digital and hard copy)
- Emails
- Standards
- Operating Procedures
- Work Instructions
- Policies and guidance
- Meeting papers and minutes
- Education material
- Reports
- Contracts
- Presentations
- Official communications
- Photographs
- Audio recordings (other than voicemail messages)
Roles and Responsibilities
Role | Responsibilities |
Document Owner | The employee or contractor who owns the document (as a creator or due to reassignment to them after the creator/last owner left the position or company). Creates, updates, archives documents based on their usefulness or sends them to legal hold. |
Department Head | 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. |
Lifecycle
All documents created in the company will follow an estatblished 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 reach. |
Create
Only CDISC systems will be used to create and/or store and/or distribute CDISC documents:
- Outlook
- Confluence Wiki
- SharePoint / OneDrive
- Azure DevOps Wiki
- GitHub Wiki
Documents will have an explicit name, category, and confidentiality.
Name - todo
Category - todo
Confidentiality - In order to maintain confidentiality, documents will be designated using one of five classifications:
- Public - Available to be viewed by anybody in the world. All documents should have a designation but any document without a designation will be considered Public.
- Members - Available to be viewed by CDISC membership.
- Internal - Available to be viewed by anybody within CDISC (employees and contractors).
- Confidential - Available to only a restricted group of CDISC employees and/or contractors.
- Classified - Available to only a restricted group of CDISC employees. The Department head has to approve sharing with anyone else.
Distribute
todo
A document is available for employees and/or the general public according to the confidentiality classification.
Use
todo
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
Document retention category
According to the time documents must be preserved, they will be categorized under any of the following categories:
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.
All documents must have a Document Revision every year. The first year is mark 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 and still needed for the company. Documents that are being use 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 followings:
- 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.
Document Update
When updating a document, the employee or contractor owner of the document needs to make sure of the following points:
- If there are links in the document, those links need to open working pages. Any dysfunctional link needs to be fix.
- When there are name of employees addressing a position within the company, specific project or similar, the names need to be update to the employee or contractor holding those positions.
- All processes and work instructions must be check to make sure that they are update 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 update.
Retention Period
Documents will stay in Retention Period for one-year to make sure they are not needed again. After one year in Retention Period, the head of the department that the document is use will take another look to 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 again after one more year for the head of the department that the document is use and decided if it needs to be deleted or needs to be reestablish to its previous location before Retention Period.
Any document can´t stay in Retention 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 Retention Period when he/she considers necessary.
- Decides if a document needs to be deleted or stay one more year after the year in the Retention Period.
- Decides if a document needs to be deleted or reestablish to its previous location after 2 years in the Retention Period.
Document management
- Documents must include name, data of creation, version, date of last update (if applicable) 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 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 to a file until a retention period is reach.
- Documents can’t have a copy on a different location.
- If there are two or more duplicate documents and one is and 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