Record test data into Word document

gnobis

Registered
Client, developing a class II medical device, wishes to record test data directly onto a word document, typing in name of tester and date work was done; however this name is not an electronic signature. Completing this test report wil be a “paperless” activity. Document will then be approved by designated approvers in their part 11 compliant electronic document management system.

We believe that FDA will not object to this practice for documents (test data/reports) included in a 510(k) submission. Rationale is the “truthful and accurate” requirement the company places on the tester and that the approvers are attesting to the truthful and accurate report by their approval.

I wanted to check with Elsmar Cove readers on their experience regarding this practice. (One of my clients followed this practice and no issues were raised in 510(k) review.)
 

Tidge

Trusted Information Resource
I've never done this with a submission to a regulatory authority. I have used Word content controls (with locked document sections) to allow a 3rd party to record observed results, but then I (personally) flattened the document to preserve the record of the executions, and 'manually' collected attestations of execution.

I did have to be somewhat clever about the content controls than I expected (more experienced folks can snicker if they like, less experienced folks don't need a reason to snicker):
  • Some Word elements (checkboxes!) are (treated like?) content controls, which I hadn't realized before this! They had just been "pasted in" to the templates by someone else.
  • Most of the content controls were text boxes. I tried to specify font/color so as to help distinguish entered data from previously approved text. (I never experimented to see if an executor could 'clobber' my choices.
  • Text box content controls can 'grow'; this can alter page counts. There probably is a way to limit this, but I didn't do this.
  • Some content controls were set up with prescribed choices(think: Null/Pass/Fail with Null as the default) ... this disallowed 'free text entry'
  • It took me some trial-and-error to lock the sections I needed locked.
I did this with a 'limber' group of professionals. Ultimately I felt like this was too much work for not enough payout.
 

yodon

Leader
Super Moderator
“truthful and accurate” requirement the company places on the tester

Just to play devil's advocate here, I'm guessing there's not a tight chain of custody between when the tester completes the entries and when the reviewers attest via e-signature; i.e., after the tester saves, someone could make changes. That might be raised as a concern since it could be argued it would fail the first 'A' in ALCOA (Attributable). (If there's a way to lock that down once the testers complete their entry then you might have a stronger case; e.g., have the testers generate a PDF or a lock on editing)

One of my clients followed this practice and no issues were raised in 510(k) review.

It's risky to think that what worked for one will work for you. Reviewers are all different. If this is a reviewer's hot-button then you're liable to be challenged. Recognize the gaps / shortfalls and have a story. They can still say you're not compliant but might not elevate it.
 
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