Hi,
First of all, in what way you want to maintain your DHF? As a large binder file or just an excel spreadsheet that references various documents?
For case ii) of excel spreadsheet, I do the following manner:
- put all the design elements such as D&D, DI, DO, DR, DVer, DVal, DT and DChange
- in each row/section, populate the documents. say for eg, under D&D you can put the development plan and any other functional plans as per your process.
In DI section, you can list down the requirements document, in DO section, specifications document, trace matrix document, risk assessment plan, risk assessment report, design drawings, etc..and in design review section, you can list down the various design review meeting minutes, followed by verification test plans, reports, validation test plans and reports, external validation, stability test plans and reports, package validation etc..in design transfer-any design transfer checklist, etc...
- for DI -product requirements document, we may have many PRD docs, each for instrument, SW,consumables, Assay and the specifications document will call for all these PRD docs, in a way, a system level PSD doc.
Many PRDs and one PSD.
- but when there is a scope to add multiple assays, then I suggest to have 2 DHFs, one for instrument (HW+FW+SW+Consumables) and another one for Assay related and it's associated kits, if any. But you need to have a link between these two. If the instrument takes multiple assays, then this has to be mentioned somewhere in the requirements/specifications document.
Hope this helps!
Regards,
Sreenu