MLV-005

The General Rules of Good Documentation Practices & Data Integrity

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

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP