MedTech Manufacturing worked example

Device History Record Time at 29% review and approval allowance: a worked example

What does the result look like when review and approval allowance reaches 29%? The full calculation is worked below with real intermediate numbers. Use this when planning production schedules that include documentation time, justifying electronic batch record (eBR) systems, or estimating QA review backlog.

The inputs for this scenario

  • DHR entries per lot: 45 entries (unchanged)
  • Entries completed per minute: 1.5 entries / min (unchanged)
  • Review and approval allowance: 29 % (raised for this scenario; the documented default is 25)

Working through the calculation

  • Applying the documented formula (Base device history record time = DHR entries per lot รท entries completed per minute) to the inputs above produces each figure below.
  • At this operating point the engine returns 38.7 min for total dhr completion time, the number this scenario is built around.
  • At this operating point the engine returns 30 min for base documentation time.
  • At this operating point the engine returns 29 % for review and approval time added.
  • At this operating point the engine returns 1.5 pieces / min for documentation entry rate.

How this compares with the baseline

  • Against the tool's baseline example, where review and approval allowance sits at 25% and the headline result is 37.5 min, this scenario comes in 3.2% above the baseline at 38.7 min.
  • A figure at this level is achievable when review and approval allowance is genuinely sustained, not just peaked for a shift. It assumes a steady entry rate and a flat review percentage; complex exception handling, deviations, or missing-data chases can add far more time than the allowance covers.

Results at a glance

  • Total DHR completion time: 38.7 min (headline result)
  • Base documentation time: 30 min
  • Review and approval time added: 29 %
  • Documentation entry rate: 1.5 pieces / min

Run it with your numbers

  • Every input above is editable in the live Device History Record Time calculator, which recalculates instantly and can be shared with the inputs intact.

Last reviewed 2026-05-12.