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Icologiq Knowledge · Concept
Controlled Copy
A formally issued copy of an approved document whose version, distribution and status are controlled so it can be updated, replaced or withdrawn when the source document changes.
Also known as:
controlled copies, controlled hard copy, controlled paper copy
At a glance
Type
Concept
Topic
Document Control
Applies to
Cross-industry
Current version
Status
Last reviewed
October 23, 2026
Definition
A controlled copy is a formally issued copy of an approved document that remains under document-control rules after distribution. The organization can identify what version was issued, where or to whom it was distributed and what must happen when that version is superseded. Controlled copies are especially relevant for paper or offline documents used at points of work where automatic access to the current electronic version cannot be assumed.
Why it matters
In MedTech and other regulated operations, a printed work instruction, form or procedure can remain physically in use long after the source document has changed. Controlled-copy practices help Quality teams prevent obsolete instructions from staying at the point of use by making issuance, location, replacement and withdrawal traceable.
The copy should originate from the current approved document rather than from an uncontrolled local file or previous print.
Issued from an approved source
•
Version, revision or other identifying information should make it possible to determine which approved source the copy represents.
Version and copy are identifiable
•
Where risk justifies it, record the recipient, location, copy number or other information needed to find the issued copy again.
Distribution is traceable
•
When a new version becomes effective, affected controlled copies should be replaced, revoked or clearly removed from operational use.
Revisions trigger replacement or withdrawal
•
Keep enough issuance and withdrawal evidence to show how the organization prevented superseded copies from remaining in use.
Status remains auditable
•
Concept explained
What makes a copy controlled
A copy becomes controlled when responsibility does not end at printing or export. Its identity, distribution and replacement remain linked to the approved source document.
A document whose creation, approval, revision, distribution and withdrawal are managed through defined controls to ensure authorized and current information is used.
Controlled Document
Concept
· Document Control
The process of ensuring that approved documents are current, traceable, accessible to the right people and protected against uncontrolled change or use.
Document Control
Process
· Document Control
The controls used to identify, approve, publish and trace document revisions so users work from the correct current version and obsolete versions remain controlled.
Document Version Control
Process
· Document Control
A controlled document or version that is no longer current for operational use but may need to be retained as historical or compliance evidence.
Obsolete Document
Concept
· Document Control
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