Writing Reports - Releasing Data into our Documentation System

[Quality_Strong]

Maybe someone might be able to provide some guidance on a hotly debated issue at my (med device) company.

We currently have two paths that one can go down when releasing data into our documentation system.

One path is using a protocol and report. The protocol contains the purpose of the study, the instructions, and acceptance criteria. All of this is approved and the protocol is released into our documentation system the study is conducted. The results and any deviations to the study as well as rationale for acceptance is contained in the report which is again approved and released into our documentation system.

The second path is to release a technical report. The technical report may contain all the same information, but it is released in one large document, similar to how you might write up a lab report in school.

Everyone agrees that for any testing that needs to be submitted to a regulatory body needs a protocol and report, but beyond that, the agreement breaks down. Does anyone have some general rules that you follow to determine if one or the other might be necessary?

 

[yodon]

Well, this has been sitting around unanswered too long. I'll stick my neck out.

I'm in medical devices and so this is certainly slanted to that field.

I re-looked at 21 CFR 820 (US FDA regulations) and ISO 13485 (international standard) and didn't see anything that required a particular approach. I have always taken the protocol - report route so I dug a bit deeper. In the FDA guide to auditing (QSIT - https://www.fda.gov/downloads/iceci/inspections/ucm142981.pdf) they get a bit closer, noting:

Confirm that acceptance criteria were established prior to the performance of verification and validation activities.

So I guess from a medical device perspective, if you take the report approach, as long as your plan (or some other mechanism) establishes the acceptance criteria, this would be acceptable.

Again, this is strictly speaking for medical devices and your industry may be different. It would point to good practice, though (otherwise, you can craft the report to match your actual results).