Estimate the business case for electronic Device History Records
Moving from paper-based or partially digital production records to an electronic Device History Record (eDHR) process may reduce manual data entry, record handling, review effort, document storage, and delays caused by incomplete records. Actual results depend on production volume, the current process, system capabilities, implementation scope, and employee adoption.
This calculator uses your own estimates rather than assuming a fixed percentage improvement. Use measured baseline data where possible, and treat the output as a planning scenario—not a guarantee of savings.
1. Enter your facility assumptions
Enter average monthly production volume, expected time savings, labor costs, and estimated eDHR investment costs.
2. Your estimated ROI results
Results are estimates based on the assumptions entered above.
Annual savings breakdown
| Savings category | Estimated annual value |
|---|---|
| Production documentation labor | $0 |
| Record review labor | $0 |
| Documentation correction labor | $0 |
| Paper and printing | $0 |
| Record administration labor | $0 |
| Other non-labor savings | $0 |
| Total annual gross savings before realization adjustment | $0 |
| Estimated benefit after realization adjustment | $0 |
| Annual software, support, and internal administration | -$0 |
| Annual net benefit after ongoing costs | $0 |
Investment summary
| One-time implementation, validation, and training | $0 |
|---|---|
| Annual recurring costs | $0 |
| Total modeled costs over three years | $0 |
| First-year ROI | — |
| Three-year ROI | — |
How the eDHR ROI calculation works
The calculator estimates annual savings from production documentation, record review, correction work, paper and printing, administration, and other non-labor savings. It then applies the savings realization percentage to reflect the fact that projected benefits may not be achieved in full.
Key formulas
- Production documentation savings: monthly batches × minutes saved per batch ÷ 60 × hourly labor cost × 12.
- Other labor savings: monthly hours saved × applicable hourly labor cost × 12.
- Adjusted annual gross savings: total estimated annual savings × savings realization percentage.
- Annual net benefit: adjusted annual gross savings − annual recurring costs.
- First-year net benefit: adjusted annual gross savings − annual recurring costs − one-time costs.
- Three-year net benefit: three years of adjusted annual gross savings − three years of recurring costs − one-time costs.
- ROI: net benefit ÷ total modeled costs × 100.
Payback is estimated using one-time costs divided by monthly net benefit after recurring costs. If monthly net benefit is zero or negative, the calculator reports that payback is not achieved under the current assumptions. The model assumes savings and recurring costs remain constant across the three-year period and does not discount future cash flows.
Frequently asked questions
What is an eDHR ROI calculator?
An eDHR ROI calculator estimates the potential financial impact of implementing electronic Device History Records. It compares estimated labor and operating savings with implementation, validation, training, software, and support costs.
What costs should be included in an eDHR business case?
Consider software licensing, configuration, integrations, data migration, validation or qualification activities where applicable, training, process redesign, internal project time, ongoing support, maintenance, and system administration. Your organization may have additional costs specific to its facilities and production processes.
How should we estimate productivity savings?
Measure the current process before implementation. Track the time needed to complete records, review them, correct errors, route documents, and retrieve historical records. Compare those measures with a representative pilot or post-implementation period, while avoiding overlap between categories.
Does a positive ROI prove that an eDHR system is compliant?
No. ROI is a financial estimate, not a compliance assessment. System suitability depends on intended use, applicable requirements, process controls, risk management, validation or assurance activities, access controls, record retention, and the organization's quality system.
Does the calculator include quality or regulatory risk reduction?
It does not automatically monetize those benefits. If your organization has reliable data to estimate the financial effect of fewer documentation errors, faster investigations, or reduced record retrieval effort, you can incorporate appropriate non-overlapping amounts into the savings inputs. Document the source and assumptions behind any such estimate.
Can I use this calculator for a business case or vendor evaluation?
Yes, as an initial planning tool. Run conservative, expected, and optimistic scenarios, validate assumptions with production, quality, IT, finance, and regulatory stakeholders, and compare vendor quotations using the same scope and time horizon.
Further reading and regulatory context
For relevant electronic records and quality-system context, consult official sources and determine which requirements apply to your products, processes, and systems.
- 21 CFR Part 11 — Electronic Records; Electronic Signatures
- FDA guidance: Part 11, Electronic Records; Electronic Signatures — Scope and Application
- FDA medical device information
This website provides general educational information and planning tools. It is not legal, regulatory, financial, or validation advice.