Original data is created when an action, result or data point is recorded for the first time.

Original data is often referred to as primary data or source data and must be retained and subject to review and approval.

Original Vs Copy

There are often many discussions about whether data is an original or a copy.

If copies are made, these documents must be labeled as copies. Care must be taken to control copies and to ensure reconciliation against the original data sources.

Scanning hardcopy original records to write the hardcopy records to a common, simple, permanent format (e.g. PDF) for retention and archival can be achieved following established process for creating, reviewing and accessing those records and subsequently archiving the original record.

Computer Systems

When validating computer systems, it’s important to consider when and where original data is created and then ensure it is preserved appropriately.

Paper Documents

Information must be recorded directly onto documents. This avoids the potential of introducing errors in transcribing information between documents.

Printouts

If information from an instrument is printed out, by the instrument, that printout is the original record and should be signed, dated and attached to the record.

Companies must be prepared during inspections as health authority inspectors are going to request original data and usually will not be satisfied with copies.

Now, let’s discuss the accuracy of data.