R for regulatory use

From: [email protected] [mailto:[email protected]] On Behalf Of Christina Halliday Sent: vrijdag 23 maart 2018 15:32 To: [email protected] Subject: [NMusers] R for regulatory use Hi Everyone As we know R has become the programming language of choice in many industries due to its cutting edge capabilities. However, R's open source nature can cause concern for heavily regulated industries and companies that have strict policies around open source usage. To overcome these concerns, Mango developed "ValidR". Mango's dedicated Validation team have been supporting ValidR customers for a number of years. ValidR delivers a controlled and validated version of open source R in line with regulatory guidelines such as FDA 21 CFR part 11. To find out more about ValidR, join our 30-minute free public webinar on Thursday 19 April. Register for your place here: https://www.mango-solutions.com/validr/ Any questions please feel free to contact us at [email protected]<mailto:[email protected]> Kind regards Christina -- LEGAL NOTICE This message is intended for the use of the named recipient(s) only and may contain confidential and / or privileged information. If you are not the intended recipient, please contact the sender and delete this message. Any unauthorised use of the information contained in this message is prohibited. Mango Business Solutions Limited is registered in England under No. 4560258 with its registered office at Suite 3, Middlesex House, Rutherford Close, Stevenage, Herts, SG1 2EF, UK. PLEASE CONSIDER THE ENVIRONMENT BEFORE PRINTING THIS EMAIL Information in this email and any attachments is confidential and intended solely for the use of the individual(s) to whom it is addressed or otherwise directed. Please note that any views or opinions presented in this email are solely those of the author and do not necessarily represent those of the Company. Finally, the recipient should check this email and any attachments for the presence of viruses. The Company accepts no liability for any damage caused by any virus transmitted by this email. All SGS services are rendered in accordance with the applicable SGS conditions of service available on request and accessible at http://www.sgs.com/en/Terms-and-Conditions.aspx

From: [email protected] [mailto:[email protected]] On Behalf Of Faelens, Ruben (Belgium) Sent: 23 March 2018 15:36 To: Christina Halliday; [email protected] Subject: [NMusers] RE: R for regulatory use Dear Christina, I would love to learn a bit more about this, and an open discussion on this list is probably the best way. Could you elaborate how specifically the open source nature of R causes concern? See the nice documentation from the R project core team at https://www.r-project.org/doc/R-FDA.pdf It seems to me that solid controls are in place, and the self-evaluation of 21 CFR part 11 by the R Core team does not result in any cause for concern. Perhaps I misinterpret or am too optimistic: Which parts of this self-evaluation document would you consider insufficient, or cause for concern? Also see https://www.r-bloggers.com/r-drug-development-and-the-fda/, https://www.r-bloggers.com/fda-r-ok-for-drug-trials/, and especially presentations/posters from people at FDA: http://user2007.org/program/presentations/soukup.pdf and http://blog.revolutionanalytics.com/downloads/FDA-Janice-Brodsky-UseR-2012.pdf I am quite allergic to people sowing fear, uncertainty and doubt on open-source software, especially when commercial off-the-shelf software is held to different standards. Best regards, Ruben Faelens From: [email protected]<mailto:[email protected]> [mailto:[email protected]] On Behalf Of Christina Halliday Sent: vrijdag 23 maart 2018 15:32 To: [email protected]<mailto:[email protected]> Subject: [NMusers] R for regulatory use Hi Everyone As we know R has become the programming language of choice in many industries due to its cutting edge capabilities. However, R's open source nature can cause concern for heavily regulated industries and companies that have strict policies around open source usage. To overcome these concerns, Mango developed "ValidR". Mango's dedicated Validation team have been supporting ValidR customers for a number of years. ValidR delivers a controlled and validated version of open source R in line with regulatory guidelines such as FDA 21 CFR part 11. To find out more about ValidR, join our 30-minute free public webinar on Thursday 19 April. Register for your place here: https://www.mango-solutions.com/validr/ Any questions please feel free to contact us at [email protected]<mailto:[email protected]> Kind regards Christina -- LEGAL NOTICE This message is intended for the use of the named recipient(s) only and may contain confidential and / or privileged information. If you are not the intended recipient, please contact the sender and delete this message. Any unauthorised use of the information contained in this message is prohibited. Mango Business Solutions Limited is registered in England under No. 4560258 with its registered office at Suite 3, Middlesex House, Rutherford Close, Stevenage, Herts, SG1 2EF, UK. PLEASE CONSIDER THE ENVIRONMENT BEFORE PRINTING THIS EMAIL Information in this email and any attachments is confidential and intended solely for the use of the individual(s) to whom it is addressed or otherwise directed. Please note that any views or opinions presented in this email are solely those of the author and do not necessarily represent those of the Company. Finally, the recipient should check this email and any attachments for the presence of viruses. The Company accepts no liability for any damage caused by any virus transmitted by this email. All SGS services are rendered in accordance with the applicable SGS conditions of service available on request and accessible at http://www.sgs.com/en/Terms-and-Conditions.aspx -- LEGAL NOTICE This message is intended for the use of the named recipient(s) only and may contain confidential and / or privileged information. If you are not the intended recipient, please contact the sender and delete this message. Any unauthorised use of the information contained in this message is prohibited. Mango Business Solutions Limited is registered in England under No. 4560258 with its registered office at Suite 3, Middlesex House, Rutherford Close, Stevenage, Herts, SG1 2EF, UK. PLEASE CONSIDER THE ENVIRONMENT BEFORE PRINTING THIS EMAIL

From: [email protected] [mailto:[email protected]] On Behalf Of Edward Gash Sent: Friday, March 23, 2018 12:20 PM To: Faelens, Ruben (Belgium) <[email protected]>; Christina Halliday <[email protected]>; [email protected] Subject: [NMusers] RE: R for regulatory use Hi Rubens, Thanks for your questions, I'm always happy to have an open discussion about ValidR. Yes the R Foundation has released information to support the use of R for regulatory work. But this only covers the Core & Recommended packages that come with a basic installation. The 12,000+ packages that are available from CRAN, BioConductor, R-Forge, Git or any other sources aren't covered. Last year Mango carried out some analysis on the percentage of packages on CRAN that had a formal test framework. The results showed that less than 22% of packages had a formal test framework. As you're probably already aware, to register a package on CRAN there are some checks required, but these don't necessarily relate to the functions contained in a particular package. In terms of the testing that Mango carries out as part of our validation, in the 3.2.5 release of R we validated 400 packages for our customers. Out of those packages we found Critical Bugs in 5 packages which meant they failed validation and should not be used. Some of these were very well know packages and bug reports were sent to the package maintainers and fixes have been made to newer versions of these packages. Mango has consulted the R Foundation and the FDA as part of our product development. In addition to this Mango is also a founding member of the R Consortium which works with and supports the R Foundation in promoting the growth and development of R as a leading platform for data science and statistical computing. I hope this gives you some of the answers or further understanding that you were looking for, but I'll be happy to talk more about the history, process and examples of customers using ValidR. Alternatively, please join us on the webinar on the 19th of April and I'll talk about this a lot more then as well. Kind regards, Ed Gash Mango Solutions From: [email protected]<mailto:[email protected]> [mailto:[email protected]] On Behalf Of Faelens, Ruben (Belgium) Sent: 23 March 2018 15:36 To: Christina Halliday; [email protected]<mailto:[email protected]> Subject: [NMusers] RE: R for regulatory use Dear Christina, I would love to learn a bit more about this, and an open discussion on this list is probably the best way. Could you elaborate how specifically the open source nature of R causes concern? See the nice documentation from the R project core team at https://www.r-project.org/doc/R-FDA.pdf It seems to me that solid controls are in place, and the self-evaluation of 21 CFR part 11 by the R Core team does not result in any cause for concern. Perhaps I misinterpret or am too optimistic: Which parts of this self-evaluation document would you consider insufficient, or cause for concern? Also see https://www.r-bloggers.com/r-drug-development-and-the-fda/, https://www.r-bloggers.com/fda-r-ok-for-drug-trials/, and especially presentations/posters from people at FDA: http://user2007.org/program/presentations/soukup.pdf and http://blog.revolutionanalytics.com/downloads/FDA-Janice-Brodsky-UseR-2012.pdf I am quite allergic to people sowing fear, uncertainty and doubt on open-source software, especially when commercial off-the-shelf software is held to different standards. Best regards, Ruben Faelens From: [email protected]<mailto:[email protected]> [mailto:[email protected]] On Behalf Of Christina Halliday Sent: vrijdag 23 maart 2018 15:32 To: [email protected]<mailto:[email protected]> Subject: [NMusers] R for regulatory use Hi Everyone As we know R has become the programming language of choice in many industries due to its cutting edge capabilities. However, R's open source nature can cause concern for heavily regulated industries and companies that have strict policies around open source usage. To overcome these concerns, Mango developed "ValidR". Mango's dedicated Validation team have been supporting ValidR customers for a number of years. ValidR delivers a controlled and validated version of open source R in line with regulatory guidelines such as FDA 21 CFR part 11. To find out more about ValidR, join our 30-minute free public webinar on Thursday 19 April. Register for your place here: https://www.mango-solutions.com/validr/ Any questions please feel free to contact us at [email protected]<mailto:[email protected]> Kind regards Christina -- LEGAL NOTICE This message is intended for the use of the named recipient(s) only and may contain confidential and / or privileged information. If you are not the intended recipient, please contact the sender and delete this message. Any unauthorised use of the information contained in this message is prohibited. Mango Business Solutions Limited is registered in England under No. 4560258 with its registered office at Suite 3, Middlesex House, Rutherford Close, Stevenage, Herts, SG1 2EF, UK. PLEASE CONSIDER THE ENVIRONMENT BEFORE PRINTING THIS EMAIL Information in this email and any attachments is confidential and intended solely for the use of the individual(s) to whom it is addressed or otherwise directed. Please note that any views or opinions presented in this email are solely those of the author and do not necessarily represent those of the Company. Finally, the recipient should check this email and any attachments for the presence of viruses. The Company accepts no liability for any damage caused by any virus transmitted by this email. All SGS services are rendered in accordance with the applicable SGS conditions of service available on request and accessible at http://www.sgs.com/en/Terms-and-Conditions.aspx -- LEGAL NOTICE This message is intended for the use of the named recipient(s) only and may contain confidential and / or privileged information. If you are not the intended recipient, please contact the sender and delete this message. Any unauthorised use of the information contained in this message is prohibited. Mango Business Solutions Limited is registered in England under No. 4560258 with its registered office at Suite 3, Middlesex House, Rutherford Close, Stevenage, Herts, SG1 2EF, UK. PLEASE CONSIDER THE ENVIRONMENT BEFORE PRINTING THIS EMAIL ________________________________ Confidentiality Notice: This message is private and may contain confidential and proprietary information. If you have received this message in error, please notify us and remove it from your system and note that you must not copy, distribute or take any action in reliance on it. Any unauthorized use or disclosure of the contents of this message is not permitted and may be unlawful.