Re: Audit Trail for Data TablesWhen it comes to regulated analysis in pharma and healthcare, it primarily falls under the purview of FDA 21 CFR Part 11 and EudraLex Annex 11, which typically extend beyond the scope of desktop-class software like JMP. However, to address such requirements for desktop users, a more comprehensive system should encompass the following features, which would be desirable in a regulated workflow for the pharmaceutical industry:
Component 1: Enhanced Log for Data Manipulation Steps
- Change Tracking Activation: Allow users to activate change tracking on a per-table basis. Once activated for a table, the system should start recording all actions related to that table.
- Action Recording: The system should capture various types of data manipulation actions, such as:
- Recoding of data.
- Changes in formulas.
- Modifications of column properties.
- Any other relevant data transformations or manipulations.
Metadata Writing: All recorded actions should be timestamped and written to the metadata of the respective data table. This metadata should include:
- The nature of the change (e.g., formula change, recoding).
- The user who made the change.
- The exact time and date of the change.
- A description or snapshot of the change (before and after states).
User Interface for Tracking: Provide a user interface where users can view the change history for each table, ideally integrated within JMP's existing interface.
Security and Access Control: Ensure that only authorized users can activate/deactivate change tracking and access the change logs.
Component 2: Tracking Individual Value Entries
- Granular Tracking: Enhanced log to track individual cell-level changes. This includes:
- Entries of new data.
- Modifications of existing data.
- Deletion of data.
Detailed Record-Keeping: For each change, the system should record:
- The specific cell (row and column) that was changed.
- The old value and the new value.
- The user who made the change.
- The exact timestamp of the change.
Integration with Enhanced Log: Integrate this granular tracking with the broader change tracking system, ensuring that all changes are captured cohesively in the table’s metadata.
Alerts and Notifications: Optionally, implement alerts for significant changes or changes that meet certain criteria (e.g., changes above a certain value threshold).
Audit Trail Interface: Provide an interface for reviewing detailed changes at the individual cell level, including filtering and searching capabilities.
Compliance and Reporting: Ensure the system supports compliance needs, including the ability to generate reports for audit purposes.
In pharmaceutical and healthcare regulated computing setups, several products come with audit trail features, each catering to specific aspects of the industry. Here is a list of some products and their respective categories:
- Epic Systems (Electronic Health Records - EHR)
- Cerner ( EHR)
- LabWare LIMS (Laboratory Information Management Systems - LIMS)
- STARLIMS ( LIMS)
- Medidata Rave (Clinical Trial Management Systems - CTMS)
- Oracle Clinical (CTMS)
- Argus Safety (Pharmacovigilance and Drug Safety Software)
- Veeva Vault Safety (Pharmacovigilance and Drug Safety Software)
- MasterControl (Quality Management Systems - QMS)
- Veeva Systems (QMS)
- Sparta Systems TrackWise (Regulatory Compliance Software)
- Pilgrim Quality Solutions (Regulatory Compliance Software)
- Phoenix WinNonlin (Pharmacokinetics and Pharmacodynamics Modeling Software)
and several others.
Re: Audit Trail for Data TablesThanks Mike and Chandra - I can just add that I know at least 5-10 customers right away asking this for years over and over again, and we had lots of discussions about the validation and requirements in the regulated environment.
Audit Trail for Data TablesWhat inspired this Wish List Request?
Over the years, customers in regulated environments have commonly asked for a method to track changes made to a data table. During recent on-site visits with strategic accounts this request was raised again. The general standard answer we have been giving to customers over the years (to use the OS's native change tracking capability) doesn't appear to be a workable solution in most cases. Given that we now track all changes in the session via the enhanced log, it seems that revisiting this request is appropriate.
Please describe the new or improved feature or solution you would like to see.
There are two components to the request
- Implement a solution that, when enabled, will capture data manipulation steps from the enhanced log (recode, formula changes, column property changes, etc.) and write them to metadata for a data table. This would be done on a table by table basis. i.e., change tracking would be turned on for a given table, and only the enhanced log actions for that table would be written to its metadata.
- Extend the change tracking capabilities of enhanced log to capture individual value entry by the user. i.e., someone goes in and changes or deletes a number.
What would the value be to you and/or other users if this new feature is provided?
This is a common request in regulated environments in the biotech, semi, and financial verticals.
Is this an external customer request?
Yes. Current request was also posted by the customer in the public wishlist: https://community.jmp.com/t5/JMP-Wish-List/Audit-Trail-for-Data-Entry/idi-p/704938#M5099
This request expands on the customer request with additional detail and historical comments from various other customers.
Is there a competitive software package that has this feature or solution that we should be aware of?
Not sure.
Will this impact a renewal, expansion, or adoption at a customer, and does this put an account at risk if we do not address this?
This would help in expansion within regulated environments in our larger customers.
Content OrganizationData AccessRe: Audit Trail for Data Tables - Status changed to: AcknowledgedRe: Audit Trail for Data TablesThanks - we get more and more request asking exactly for this.
Re: Audit Trail for Data TablesYes, same here. Thank you for this post.
