Initial Documents in MedQdoc #
Initial documents in MedQdoc are predefined document templates provided by MedQdoc. These documents are delivered as actual documents with a special document lifecycle status called Initial.
Initial documents are used to deliver complete template libraries for QMS, MDR, IVDR, QSR, and technical documentation in a controlled and compliant way.
What Are Initial Documents? #
Initial documents are full document templates created and maintained by MedQdoc. They are not drafts or examples – they are real documents that must be activated and processed through the full document lifecycle before they can be used by your organization.
The Initial status indicates that the document has not yet been adopted into your organization’s QMS.
When Are Initial Documents Provided? #
When a MedQdoc site is installed for a customer, a complete set of Initial documents can be provided upon request. These documents cover:
- QMS documentation templates
- MDR and IVDR technical documentation templates
- Regulatory and compliance-related templates
Before these documents can be used, they must be activated and approved by your organization.
Activating Initial Documents #
To start using Initial documents, they must first be activated as drafts.
Activation process:
- Initial documents are delivered with the status Initial.
- An administrator activates the document as a Draft.
- The document must then pass through the full document lifecycle: Draft → Review → Approve → Published.
Once published, the document officially becomes part of your organization’s QMS and template library.
Using Initial Documents After Publication #
After an Initial document has been published:
- It becomes part of your organization’s approved template library.
- It can be used to create new documents.
- It is included in audits and compliance reviews.
This ensures that all templates used by the organization are formally approved and traceable.
Updates to Initial Templates #
MedQdoc may periodically provide new or updated Initial documents. If this occurs, you will first be asked whether you want these updates added to your site.
If accepted:
- The updated documents are added with status Initial.
- You must activate them as drafts.
- The documents must again follow the full document lifecycle before use.
This ensures that your organization always controls which templates are included in the QMS.
Summary #
Initial documents are the official way MedQdoc delivers all QMS, MDR, IVDR, QSR, and technical documentation templates. They must be activated, reviewed, approved, and published by your organization before they can be used.
