The intent of the DHR (Device history Record) is to provide evidence that the device lot or batch was manufactured in accordance with the DMR. Though minimum requirements for a DHR are identified in 21 CFR 820.184, it is not uncommon for a DHR to contain or reference the following information (as applicable to the product manufactured).
1. Details of Finished device batch, lot or serial number
2. Materials used and may identifiers (part number, control number)
3. Manufacturing dates
4. Quantity started and completed
5. Quantity released
6. Details of testing and inspection records
7. Primary Labeling
8. Identification of individuals performing the operations
9. Documents utilized
10. References to appropriate nonconforming material reports.
If software is part of the device, the details of the software version, assembling in to the device, results from evaluating the device software, will be included in the DHR and it’s provide a manufacturer with traceability.
Thanks and Regards
S. Subramaniam
I believe this is a software device - not necessarily software as part of a device, since this is a software company. These requirements for DHR are still applicable.
For software devices, DHR's usually identify the production part number for the software, list the parts (executables, media, instructions, etc), the procedures for "manufacturing" (how the software is copied and packaged, issue of serial number, etc), QC testing procedures, and final acceptance procedures. Of course... dates and individuals performing all of these activities are recorded in the DHR.
Depending on how your procedures are written, you can construct a DHR to suit your needs. I've seen DHRs as one or two sheet summaries, and I've seen them actually include the procedures used for that batch.
Your DHR could represent a single serial number or a batch of serial numbers, again depending on how you've defined your manufacturing process.
In the end, the intent of the DHR is to record the manufacturing and acceptance activities. It should paint a clear picture of the entire manufacturing process from the issue of components to the final release, and will describe all of the material, equipment and processes used for that batch to assemble, test, and release the product.