Are Copies as Acceptable as Original Documents?

This is a question that I seem to be hearing with increasing frequency! I think the reason for this is that an increasing number of companies and organizations are introducing electronic document management systems (EDMS). Where there are hard-copy records generated, these are digitized (scanned) and the resulting electronic files uploaded into the EDMS. The question then remains: What do I do with the original source paper records?

On Thursday 1st December this question will be addressed at the Drug Information Association (DIA) Electronic Document Management conference in Zurich. Lisa Mulcahy (Mulcahy Consulting) and Steve Scribner (International Life Science Solutions) will be presenting a framework that has been developed by a Special Interest Area Community to facilitate the destruction of original records following digitization. Of course, there are caveats to this process and Lisa/Steve will be outlining what some of those caveats are, including the certification of copies to provide assurance that the copy is a complete and accurate representation of the original record.

Incidentally, this question was put to FDA GCP Questions some time ago with the following response given:

“The scanning of study records to CDs and/or pdf files is acceptable for clinical trials provided the scanning process ensures that the resulting copy contains all of the original attributes and information found in the original records and someone certifies, after verification, that the records are an accurate and complete reflection of the original.

If you wish to use the scanned copies in lieu of the paper source data, (i.e. destroy the paper source data) then the scanned copies would have to meet the definition of a certified copy as described in our guidances. If you wish to retain these copies in electronic form in lieu of paper your computer system would have to comply with part 11 [21CFR11]. 

Certification should be accomplished by having the person who makes the copy, sign or initial and date the copy to indicate it meets the requirements of a certified copy as described above. This should be described in the SOP and can be accomplished by initialing and dating each copy or by initialing and dating a document certifying copies in bulk. Whichever method is used the SOP should describe the procedure.”

I find the reference to certifying copies in bulk particularly interesting as companies often ask whether each individual page or individual document needs to be certified. The process of certifying documents in batches or in bulk has long been the practice in the world of microfilming so it makes absolute sense to accept the same principle in the world of electronic digitization too.

Advertisements

About rammellel

Records management consultant to the life sciences / pharmaceutical industry
This entry was posted in Compliance, e-records, Litigation, Records management practice, TMF. Bookmark the permalink.

2 Responses to Are Copies as Acceptable as Original Documents?

  1. I would be very interested in the framework and the discussion during the DIA. In the Netherlands the DARQA (www.darqa.org) is adressing this issue with the Dutch inspectorate. The inspectorate considers that the law on archiving applicable to govermental archives also applies to clinical studies. This legislation does not allow substitution.

  2. rammellel says:

    Thank you for the comment Jan. It would be very useful to have the specific reference/citation that prohibits the digitization of paper records for archival purposes so that this can be followed up with the EMA and by the DIA Working Group.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s