True Copy Verification Explained – Paperless GxP Systems

In digital GxP systems like quality management and validation management systems, we can complete GxP documents such as validation protocols digitally. However, we still face a challenge with equipment in our factories that produce physical records. How do we avoid ending up with hybrid records, where part is digital and part is physical? The solution is through true copy verification.

The Verification Process

1. Determine if the evidence is a physical or digital record. If physical, make a digital copy.
2. Ask: Is this an original?
   • An original could be a digitally signed PDF with its full audit trail, which doesn’t need verification.
   • If it’s a copy, proceed to the next question.
3. Is the record dynamic?
   • If dynamic, we cannot verify it as a true copy. We might take a screenshot but must refer to the validated source.
   • If static, move to the final question.
4. What is the risk level?
   • Lower risk (e.g., early-stage documents): One person verifying the copy is sufficient.
   • Higher risk (e.g., batch records): Two-person verification is required.

Implementing True Copy Verification

1. Review the original hard copy and the digital scan.
2. Have one or two people sign, depending on the risk level.
3. Upload the certified true copy into a validated GxP system.

The true copy is now defined as an exact digital replica of the original documentation.

Handling Original Documents

After verification, you have two options for the original:

1. Destroy it immediately if your site is experienced with true copy verification.
2. Wait until the associated document is approved before destroying the original.