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JMP Validation-Qualification Suite to Boost Regulatory Compliance and Sales

Chandramouli_R

What inspired this Wish List Request?

To develop and integrate a qualification validation suite into JMP, based on the feedback from our pharmaceutical customers in India and the APxJ region. This enhancement is identified as a key requirement for facilitating regulatory submissions and was strongly emphasized during consultations with major clients such as Biocon, Cytel, Viatris, Lupin, and Dr. Reddy’s. This suite aims to address a universal need across various jurisdictions, thereby serving regulated pharmaceutical markets worldwide. The implementation of this feature is essential for adhering to the stringent compliance standards required in these industries globally, enhancing our product’s utility and compliance efficacy.

Please describe the new or improved feature or solution you would like to see.

We propose the development of a new qualification validation suite for JMP, designed to streamline the validation process significantly. This suite would include Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) modules, each capable of generating comprehensive, traceable, and compliant reports crucial for regulatory submissions. Emphasizing ease of integration with existing JMP workflows, this suite would automate validation, allowing test results to be obtained rapidly and reliably, reducing the validation process. This solution would support a broad spectrum of tests, providing documentation of activities through automatically generated validation reports. The validation suite would ensure compliance with global regulatory standards, including those set by the USFDA, ICH EudraLex, and the emerging requirements of ICH E6 Good Clinical Practice (GCP) R2. This strategic enhancement will enable pharmaceutical companies to confidently utilize JMP for critical regulatory submissions, thereby expanding its market applicability and strengthening its competitive position.

What would the value be to you and/or other users if this new feature is provided?

Implementing this feature would substantially increase JMP's attractiveness and utility in regulatory environments, potentially increasing license sales significantly (estimated 600-800 licenses across four customers). It would ensure that JMP meets the rigorous standards required for submission to regulatory bodies like the USFDA, ICH and EMA, thereby enhancing customer trust and satisfaction.

Is this an external customer request?

Yes, this is directly based on the needs and feedback of external customers, as evidenced by our interactions with several key pharmaceutical companies in India and APxJ.

Is there a competitive software package that has this feature or solution that we should be aware of?

Competitors like Minitab, Phoenix WinNonlin (example attached), Slim Stat, and ASAP Prime currently offer similar qualification suites, which are favored by firms for regulatory submissions. Our lack of this capability is noted as a disadvantage in the market by our users.

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?

Yes, the absence of this feature has already impacted our sales and could hinder future renewals and expansions. Not addressing this need puts us at risk of losing potential sales to competitors, particularly impacting our market share and customer retention in the pharmaceutical sector.

WLN_VALIDATION (1).pdf

ValSuiteReport11172022341PM.Failed (2).pdf

Status: In Review

Comments

lkimhui

Thanks for this request. Nevertheless, this validation package will help strengthen Pharma company submission to agencies, streamline validation processes, and ease up validation documentation workload, especially true for Indian Pharma companies whereby the level of stringentness could be tighter.

Zhaobin

Thank you, Chandra! JMP Validation-Qualification Suite is must to have tool which will make JMP on the right stage for potential mass adoption as this is one of the key requirements for Pharma industry in Asia,

HyeWonJung

Many pharmaceutical companies in Korea use SAS and are accustomed to conducting annual SAS IQ, OQ, PQ validations as per their SOPs. Therefore, if JMP is to be adopted as software submitted to regulatory agencies, customers often ask if similar procedures are in place. Therefore, customers inquire whether a validation qualification suite is available for JMP, which would be a useful addition.

ChulHee_JMP

Thanks @Chandramouli_R!

Minitab is still a strong competitor in Korean Pharma and biotech industries. The fact that Minitab provides the validation kit pivots as a protection to JMP from penetrating the market.

Jeremy_Tee

Thanks for putting in this request, Chandra. This is absolutely critical for higher adoption of JMP across Pharmaceutical companies in Asia. Having this qualification suite in place will only make JMP stronger and even more attractive for the Pharma industry.

Chris_Kirchberg

Definitely a Must if we are going to be a leader in the pharma space and make claims that pharma is one of our key industries we focus on.

DaeYun_Kim

Absolutely, @Chandramouli_R !

It's well-recognized that the pharmaceutical industry operates within a highly regulated framework, with regulatory agencies playing a pivotal role. The incorporation of such features is imperative for most pharmaceutical companies.

Having these capabilities integrated into JMP would undoubtedly elevate its efficacy and utility within the pharmaceutical sector.

Alex_Xu

Fully agree and support Chandra's professional opinion.

We do encounter the same issues and challenges in Greater China's business expansion in the pharmaceutical industry.

Just take Minitab as an example, some of our opportunity customers highly recognize the JMP product and its value, but at the same time, they think that the Validation Kit provided by Minitab (web link below) can significantly save their internal communication and paper work cost, therefore, some opportunities are lost. I have also given feedback and materials to our product and customer care departments.

Minitab Validation Kit for Pahama Industry

We still try to guide and assist our customers through the process, but it would be nice if we had an official and authoritative JMP Validation-Qualification Suite!

Thanks @Chandramouli_R!

Byron_JMP

I really like this idea of providing a PRINTABLE validation report that looks clean and tidy for documenting the installation validation.

This is a pivotal feature for Pharma.

LuveenVisnu

Thank you for submitting this request, Chandra. This is crucial for driving greater adoption of JMP within pharmaceutical companies across Asia. Implementing this qualification suite will enhance JMP's capabilities and further solidify its appeal to the pharmaceutical industry.

mia_stephens

Valerie_Nedbal

Hi @Chandramouli_R , as you know, Drew is working on an addin. So work in progress.

PatrickGiuliano

I also highly advocate for this one! I would add that this could be leveraged with some additional though to not just pharma and biopharma but also for Medtech companies! In particular for companies working on combination products (drug devices) but also for non-combo products. The validation rigor in this type of kit would very much support these kinds of organizations and could help expand our reach into them. Also since they are becoming increasingly multidisciplinary (developing enhanced software integration, personal healthcare monitoring solutions, and robotic surgery solutions), this offering will give us an increasingly competitive position in what used to be traditional high-tech industry sectors now moving into the Medtech space.

PatrickGiuliano

Horray!

Validation Suite is released.

From @Valerie_Nedbal, sent on 05/08/2026:

"JMP Validation Suite is out on the JMP market place: Validation Suite. Thanks Drew Foglia to make it happen. The JMP Validation Suite enables you to validate JMP®, JMP Pro®, and JMP Clinical® version 19 and beyond. It seamlessly runs Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), and generates PDF report files documenting each validation step. It is very useful for highly compliant industries like pharma and biotech. This was a long outstanding request initially from customers in India but will have an impact in other regions in the world too."

c/c @Chandramouli_R