5.8 Version and change control

All controlled objects and outputs shall be versioned.

For each version, the organisation shall record:

object UID;

version identifier;

status;

date and time created;

effective date or period, where known;

author or originating process;

reviewer and approver, where required;

reason for change;

evidence supporting the change;

relationship to the preceding version; and

outputs affected by the change.

A correction of a transcription or capture error shall preserve evidence of what was corrected, by whom, when and why. A change reflecting a new real-world fact or new evidence shall create a new version.

Previous approved versions shall be retained for the period defined under 13.8.