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
- Standard 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 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 made, those changes need to be documented within the document. |
| Archive | This will occur when a document is no longer required. (Currently, disposal of documents is not addressed) |
Create
Only CDISC systems and licensed applications 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, retention category, and confidentiality.
Name - The name of the document will be different according to the type. 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
Stability Category - Stability Category refers to the reliability of a document and if it will need ongoing maintenance.
- Class A - This kind of document will be kept without any modification since it was created for an event in the past. Examples of these 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 need to be reviewed by the owner to decide if the document is reliable or if it needs an update.
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
A document is available for employees and/or the general public according to the confidentiality classification.
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)
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 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 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 updated and still needed for the company. Documents that are being 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 following:
- 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 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:
- If there are links in the document, those links need to open working pages. Any dysfunctional link needs to be fixed.
- When there are names of employees addressing a position within the company, specific project, or similar, the names need to be updated to the employee or contractor holding those positions.
- All processes and work instructions must be check to make sure that they are 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 updated.
Document management
- 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.
Dispose
Before any document could be disposed, it needs to be sent to an Archived Period where the document will follow some steps before is deleted.
Archived Period
Documents will stay in Archived Period for one year to make sure they are not needed again. After one year in Archived Period, the head of the department, for which the document is used will take another look 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 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 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.
- 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 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.