General Rules of Good Documentation Practices & Data Integrity
Documentation in a regulated environment is not only a tool, but a legally binding record.
For this reason, signing for someone else is a falsification and a violation of law.
Backdating is also a falsification and violation of law.
These basic requirements fit into a larger set of principles known as “ALCOA+,” that are central to Good Documentation Practices and Data Integrity.
In general, here are the basic requirements you need to remember:
- Always record entries at the time they occur – don’t pre-or post-date documents
- Always record entries with the date and your signature/initials
- Always use indelible ink, not pencil or water-soluble ink
- Never use white-out to correct entries
- Never sign for someone else. Only sign for work that you have performed or annotate if different
- Never back-date GMP records
- Never discard original raw data or GMP records if still in their retention period
- Only record on controlled documents
- Be consistent in wording whenever possible
- And Never obliterate an entry by scribbling over it to render it unreadable