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JMP and compliance with 21 CFR Part 11

flo_kussener

Hi,

A French customer challenges us with the following FDA Regulation: 21 CFR Part 11

What is in mind of customer is having a capture of all steps in the analysis (and data table).
we can imagine some way to do that (dashboard/application/scripting/database), but perhaps some of you have some recommendation or usual answer to do to customer.

Thank a lot and have a nice christmas!

Florence

Accepted answers

Jeff_Perkinson

The best answer for this comes from JMP® Research and Development: A Process for Quality which is available from jmp.com/qualitystatement.

FDA-Regulated Industries and Compliance with CFR Title 21 Part 11

For purposes of U.S. Food and Drug Administration (FDA) validation, JMP should be considered a tool, just as SAS is considered a tool.

JMP customers who are FDA-regulated might be expected to validate the systems that they build with JMP. Because JMP is a tool, the user must show the FDA that JMP is being used correctly. See “Complying with United States Code of Federal Regulations, Title 21 Part 11ʺ in Appendix 1: “FDA-related issues” in “The Quality Imperative” for more information.

Customers can re-create analyses by saving JMP Scripting Language scripts with a JMP data table. Customers can then use JMP to explore and analyze. When the analysis is complete, customers can save the JMP script to the data table. The JMP report can have date and time information embedded. Customers should keep the data table with the JMP script attached and the JMP report in the source control system as a read-only file. If any changes are needed in the future, customers can use the source control system to check the data table out, make the changes, and check the file back in.

The FDA has adopted a SAS transport format as the standard for accepting and archiving data sets. See the FDA and SAS Technology web page (www.sas.com/govedu/fda/index.html). Note that JMP software can read and write transport format.

Because JMP provides interfaces to SAS software, all of the techniques that are described in Appendix 1: “FDA-related issues” in “The Quality Imperative” are available to JMP customers who also have SAS installed.

This language has been vetted by development and legal. It's best not to try to paraphrase this and, instead, just refer customers to this statement at jmp.com/qualitystatement.

All comments

Chris_Kirchberg

Hi Florence,
Since JMP exploratory analysis software is not compliant (and can only enable compliance) it is likely that is will not become compliant in the near future. With that said, Predictum has used JSL to help companies make a compliant environment around JMP to help satisfy these needs.
http://www.predictum.com/
There may be other partners out there that could develop an environment (using JSL) to make a compliant environment around JMP.
Does that help?
Chris

Jeff_Perkinson

The best answer for this comes from JMP® Research and Development: A Process for Quality which is available from jmp.com/qualitystatement.

FDA-Regulated Industries and Compliance with CFR Title 21 Part 11

For purposes of U.S. Food and Drug Administration (FDA) validation, JMP should be considered a tool, just as SAS is considered a tool.

JMP customers who are FDA-regulated might be expected to validate the systems that they build with JMP. Because JMP is a tool, the user must show the FDA that JMP is being used correctly. See “Complying with United States Code of Federal Regulations, Title 21 Part 11ʺ in Appendix 1: “FDA-related issues” in “The Quality Imperative” for more information.

Customers can re-create analyses by saving JMP Scripting Language scripts with a JMP data table. Customers can then use JMP to explore and analyze. When the analysis is complete, customers can save the JMP script to the data table. The JMP report can have date and time information embedded. Customers should keep the data table with the JMP script attached and the JMP report in the source control system as a read-only file. If any changes are needed in the future, customers can use the source control system to check the data table out, make the changes, and check the file back in.

The FDA has adopted a SAS transport format as the standard for accepting and archiving data sets. See the FDA and SAS Technology web page (www.sas.com/govedu/fda/index.html). Note that JMP software can read and write transport format.

Because JMP provides interfaces to SAS software, all of the techniques that are described in Appendix 1: “FDA-related issues” in “The Quality Imperative” are available to JMP customers who also have SAS installed.

This language has been vetted by development and legal. It's best not to try to paraphrase this and, instead, just refer customers to this statement at jmp.com/qualitystatement.

Chris_Kirchberg

I would like to do a quick update to this to add JMP Clinical is also in the same boat regarding this. Here is some additional links to help with this discussion to customers:

A new page was added to the JMP Clinical documentation that spells how JMPC uses data. While it doesn’t address the concern about whether or not audit trails are needed for JMPC. What it does do is provide a reasonably solid reference to say that JMPC doesn’t change, modify, delete records in the source data.

This is the statement in the documentation: From our discussion the key phrase that "JMP Clinical only reads data from the input study folder.” is in the second paragraph.

http://www.jmp.com/support/downloads/clinical_documentation/clinical_getting_started.01.44.html

This page has a note on the bottom that refers to "Systems Operations”, which leads to the page above.

http://www.jmp.com/support/downloads/clinical_documentation/clinical_getting_started.01.02.html

Also, Here are links to documents found at teh Quality Statement page for JMP that also apply:

Here is the pdf that says JMP products are part of the SAS Quality Imperative ( (FDA-Regulated Industries and Compliance with CFR Title 21 Part 11):

http://www.sas.com/content/dam/SAS/en_us/doc/whitepaper1/quality-imperative-commitment-to-quality-106810.pdf

And this document talks about JMP specifically (FDA-Regulated Industries and Compliance with CFR Title 21 Part 11)

https://www.jmp.com/content/dam/jmp/documents/en/white-papers/wp-jmp-rd-quality.pdf

Lastly, JMP Clinical comes with SAS IQ/OQ tools to help with the validation.

Chris