Current, not reconstructed later
Records are updated as work happens, avoiding a scramble to reassemble history months after the fact.
What's included
What stays current in the DM file
- Data management plan, edit check specifications, and coding conventions kept in their current, version-controlled state
- Correspondence, decision logs, and deviation records filed as they occur, not reconstructed after the fact
- Document versions tracked against SOP-defined naming and approval conventions
- Periodic self-checks against the inspection readiness file structure to catch gaps before an audit does
- Access and edit history preserved to support full audit traceability
Supports inspection readiness
Keeps the DM file aligned with NoyMed's broader inspection readiness practices.