Qynetic CIM
What is Qynetic CIM (Control Instructions Manager)?
CIM manages articles, drawings, drawing revisions, characteristics, inspection methods and frequencies, operator instructions, manual measurements and the electronic device history record (EDHR), with strict revision control so there is never ambiguity about which revision or instruction was active for a production record.
The problem it addresses
In regulated manufacturing it must always be provable which drawing revision and which instruction applied to a given part or batch. Paper, spreadsheets and disconnected systems make that fragile.
How it works
- 1Every measurement and production record references the exact revision and instruction that were in force.
- 2Released revisions are immutable; a change creates a new revision with an effective date.
- 3Traceability is preserved from article to batch to measurement to result.
Capabilities
Revision control
Drawings, characteristics and instructions with effective dates and a clear history.
Interactive drawings
Characteristics tied to the drawing so operators and inspectors see what to measure and how.
Inspection plans
Methods and frequencies per characteristic, including manual measurements.
EDHR and traceability
A device history record assembled from production, measurement and quality data.
Designed to connect to: PLM · ERP · QMS · Inspection devices. Integrations
Common questions
What is an EDHR?
An electronic device history record is the record showing that a medical device was made according to its specifications, including what was produced, which instructions and revisions applied, and the inspection and acceptance results.
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