Hi Folks
I am circling back on this question I posted a while back.
We are in the process of developing our design controls and have a few questions. We use electronic lab notebooks, which are controlled, for our design work.
The experiments that we intend to run are approved first before we start the work, with the acceptance criteria stated. The experiments we run have approved work instructions for each part of the process. The tests are then run, with the results documented in the same lab notebook that was approved previously. If the experiment does not meet the acceptance criteria, we document the next steps in the lab notebook, and send it out for approval. If the experiment passes all the pre-defined acceptance criteria, the lab notebook is reviewed/approved and the information from the lab notebook is entered into what we call a final release report ( think of it as a test summary report). This final report is then approved and reviewed. This is used as our evidence that we met the verification of the product design. For validation, we rely on our end user to proved feedback that the product meets their intended need.
During the initial design process we get all the user and product requirements that is needed to determine what the product requirements should be. So it seems we have our initial product requirements determined, we determine what testing is needed to meet the requirements, execute the verification tests, then send the sample to the end use for confirmation. During each phase of development we have a design review to ensure all functions are in agreement at various stages.
From the description above, does this sound like we are on the right track.
What I am trying to answer, I guess, does the documentation stored in the lab notebooks, and the final release report serve as my verification that the product meets the design inputs (product requirements)? Or do I need to take this further and have to create an number of test plans/protocols, which are already included in the lab notebooks, a have these as separate documents?
Any advice is always appreciated.
I am circling back on this question I posted a while back.
We are in the process of developing our design controls and have a few questions. We use electronic lab notebooks, which are controlled, for our design work.
The experiments that we intend to run are approved first before we start the work, with the acceptance criteria stated. The experiments we run have approved work instructions for each part of the process. The tests are then run, with the results documented in the same lab notebook that was approved previously. If the experiment does not meet the acceptance criteria, we document the next steps in the lab notebook, and send it out for approval. If the experiment passes all the pre-defined acceptance criteria, the lab notebook is reviewed/approved and the information from the lab notebook is entered into what we call a final release report ( think of it as a test summary report). This final report is then approved and reviewed. This is used as our evidence that we met the verification of the product design. For validation, we rely on our end user to proved feedback that the product meets their intended need.
During the initial design process we get all the user and product requirements that is needed to determine what the product requirements should be. So it seems we have our initial product requirements determined, we determine what testing is needed to meet the requirements, execute the verification tests, then send the sample to the end use for confirmation. During each phase of development we have a design review to ensure all functions are in agreement at various stages.
From the description above, does this sound like we are on the right track.
What I am trying to answer, I guess, does the documentation stored in the lab notebooks, and the final release report serve as my verification that the product meets the design inputs (product requirements)? Or do I need to take this further and have to create an number of test plans/protocols, which are already included in the lab notebooks, a have these as separate documents?
Any advice is always appreciated.