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- Medical Devices QMS
- Process
- Document acknowledgment
Document acknowledgment
A controlled document keeps the title, version, effective date, attachment and status that identify a working revision. A training acknowledgment points to that document and the person who acknowledged it. This lets the team read the person's acknowledgment in the context of a specific record.
Step by step
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Prepare revision Document Controller
Document Controller enters the title, version, effective date and file.
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Review document Document Controller
The team examines the revision while it is in Review.
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Record document state Document Controller
Document Controller records the agreed document status after review.
- Keeps the document status visible
- Updates Controlled documents
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Record acknowledgment Document Controller
Document Controller links a person to the controlled document and records the acknowledgment date.
- Links a person and date to the revision
- Updates Training acknowledgments, Controlled documents, People
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Find the revision Quality Reviewer
Quality Reviewer checks the document and acknowledgment relationship when reviewing the operating case.
- Shows the document behind the acknowledgment
- Updates Controlled documents, Training acknowledgments
Who does what
Roles and permissions- Document Controller
- Maintains records and acknowledgments.
- Quality Reviewer
- Examines the approved revision.
- Inspector
- Uses the relevant instruction.
Set up Medical Devices QMS your way.
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