Lab Document Control : Genial Genetics

iPassport QMS provides the user with a complete document management system; the system accomplishes this through a comprehensive document tracking facility.

The document control used by the iPassport QMS system provides users with a complete document management system, every aspect of the documents life is recorded, from the initial draft release to the completion of the first release version. This task driven, change management approach enables the system to faithfully record exactly what the user has created. And, as this information is held within iPassport QMS's secure database there is no possibility of the document management process being tampered with in any way.

For example when creating a SOP document the user moves through creating the SOP document, to the document being reviewed, authorised and then finally the document moves to the publishing phase. This process change management approach ensures that document tracking and auditing is made simple for the user.

Every time a user enters a SOP document with the intention of amending it the system records what staff member is trying to perform the task and once they have made their changes the system records these changes, thus providing a complete audit trail.

All members of staff that have access to the SOP document have the ability to request a change, through the change management process or post a comment on the document. However, after this they are limited to what they can accomplish on the document by their laboratory/ department role.

Therefore if the staff member does not have the role to amend a document or publish one then they will not be allowed to perform this task by the system, this ensures that document control is enforced.