Downloads

CAPA's - What are auditors or inspectors expecting to see?

Thoughts on CAPA's - 
based on my experience as a Notified Body and MDSAP auditor.
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Software requiring validation

Thoughts on software validation - based on 15 years experience.
DOWNLOAD SOFTWARE REQUIRING VALIDATION

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Software requiring validation - examples

A brain storming list - based on 15 years experience.
DOWNLOAD EXAMPLES OF SOFTWARE REQUIRING VALIDATION

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Calibration - What are auditors and inspectors expecting to see?

Thoughts on Calibration - based on my experience as a Notified Body and MDSAP auditor.
DOWNLOAD CALIBRATION

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