Scrap Paper and Post-Its
You should always enter data directly into the controlled record, as this is considered the original.
Never enter data on scrap paper to be transcribed later.
Why?
If inspectors see scraps of paper that look like original data, compliance is immediately questioned and can be a sticking point throughout the audit.
It’s important to note that if scrap paper or post-it notes are used to record information, that becomes “original data” and needs to be retained as an attachment or attached directly to the record.
Many companies have banned post-it notes from their office and production areas to avoid these issues.
If operations, tasks, or tests are performed in parallel and the original document must be in two places at the one time, then GMP forms or logbooks must be used.
The information from these sources has an audit trail and can be transcribed into the original document at a later date.
