Certified Copies – Validated Copy Process

You have chosen to generate certified copies using a validated copy process. A validated process can best be explained using the definition of validation applicable to computer systems (Source: Computer System Validation in Clinical Research – A Practical Guide, ACDM/PSI):

  • Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes; or
  • The demonstration that a [computerised] system is suitable for its intended purpose.

A validated certified copying process therefore requires the following to be in place:

  • A documented description of the process to be followed. This will include your minimum quality attributes and any minimum specifications for the equipment that will be used for copying (e.g. mandatory scanner settings);
  • Evidence that personnel making copies are aware of the required process and, if appropriate, have evidence of being trained;
  • Evidence that the prescribed process is effective at producing exact copies – this can be achieved by performing tests when the process is first developed (equivalent to User Acceptance Testing for a computerised system). We recommend using a standard Test Target document for demonstrating the completeness and quality of the copy, as described in ISO 12653;
  • Evidence of periodic risk-based quality control checks (QC) to provide assurance of the reliability of the process.

The published EMA guidance document on the Trial Master File  suggests what you might include in these QC checks:

  • congruency of the information contained between original and certified copy;
  • accuracy of the metadata attributed to the document (when applicable);
  • accuracy of file name; including that it is marked as an updated version of an already existing document;
  • quality of the image (suitable resolution to allow readability as per the original, legibility and reproduction of colour — when the colour gives meaning and legibility of wet-ink signatures or annotations and handwriting in general etc. (when applicable));
  • the eTMF audit trail associated with the document (when applicable);
  • approval of the certification process (when applicable);

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