Audit trails in ClinicalHi all,
I've had the query below from one of our Clinical customers:
As part of an internal periodic review of JMP Clinical, a question has arisen concerning the audit trail capabilities written into the software.
Please would it be possible to provide a quick technical summary of the audit trail functionality built into the JMP Clinical software?
Having had a search on here, I assume the answer is that Clinical does not have this functionality, as per: Solved: JMP and compliance with 21 CFR Part 11 - JMP User Community, and that I should direct them to the quality statement as described by Jeff Perkinson. As such, I was just hoping to get confirmation that this position hasn't changed and isn't changing with the next Clinical release.
Many thanks in advance
Stuart
Re: Audit trails in ClinicalYes to what @Chris_Kirchberg said. Almost all of the audit trail needs revolve around data, and in this situation, it is incumbent on the user to determine how to manage data and to create an audit trail. JMP Clinical has some data management tools that allow you to take a snapshot of a study and then update with new data, and you can get a report of what changed, which would aid in building an audit trail.
@Stuart_Little I would like to know more, however, about who the customer is and what it is they see lacking in the product.
Re: Audit trails in ClinicalSince JMP Clinical 17 is re-written in JSL, many of its activities are logged in the Enhanced Log. However, not everything is recorded like what is selected in a graph and which action button is selected next. There are references to which JSL file is used and variables that are used for that file. Some of it is cryptic and not really documented as to what is going on. I would not use it verbatim as to an audit trail. What @Jeff_Perkinson wrote in 2016 still stand. JMP (and JMP Clinical) is a tool, not a system (even if we sometimes refer to it as a system), so 21 CFR Part 11 does not apply.
One might use the Enhanced Log (aka Action Recorder) to help create an audit trail a long with any files that might be written, but these are all temporary and a script would have to be written to capture all of it and store it somewhere if an audit trail is needed.
A more effective process (especially around risk assessment and mitigation around tools) would be a proper SOP of use and training on the SOP and tool.
Re: Audit trails in ClinicalTo build a bit on the first part of @Jeff_Perkinson 's answer from 2016, would recording the work using the Workflow Builder make demonstrating the methods used easier?
