Electronic Device History Record (eDHR) Software Recommendations



Is anyone using Part 11 compliant computer software for DHR generation? If yes, what? Would you recommend it? Why or why not?

Our current system is paper-based and we have issues with incomplete or incorrect entries. We are interested in software where the information is entered, approved, and stored electronically with the option to print the completed record if necessary. Preferably the software would have integrated data validation to prevent improper entries and alert system if the entry is skipped or is out of specification. It would be a bonus if it could interface with other systems or software to pull in data but isn't required.




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I think it depends on what you are manufacturing and as a result how detailed DHR you are expecting to get as a result (also, consider your budget, such program may cost a lot).
We have had a paper-DHRs in the past but some time ago we've switched to an ERP software configured specifically for our needs. And I could say - if you have many incorrect records in paper forms than it will be very hard to have error-free electronic records, at least this is how it is in my experience. If you expect to have a perfect DHR out of the program I doubt there's an off-the-shelf solution, which means there shall be a relatively sophisticated software validation plan carried out.

If the only reason you are thinking on getting the software capable of producing decent DHR are mistakes in paper forms then if I were you I'd try to improve the paper forms and hope for the best. There must be a reason why there are incorrect records and from my experience it's usually not the lack of electronic records.

Of course I'm writing solely from my experience. It depends on how work is organized in your company (e.g. one person completing one DHR, several people working on single DHR etc.) and I also do not claim I know everything about software capable to produce DHR. Maybe there's a perfect off-the-shelf solution I know nothing about.
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