Regulatory Open Forum

Dear colleagues, hello! 👋

It is now clear that rapid advancement in AI/ML is transforming life around us, including the nature of work in QA/RA space.

I have been curious about this trend specifically how it is affecting the nature of our work and what it means for career advancement.

According to a recent report from McKinsey Global Institute, generative AI is poised to drive automation even in professions that involve "expertise, interaction with people, and creativity". They estimate that by 2030, automation could account for upto 30% of the hours worked in the US economy. 

Recently, I asked this question to my colleagues on LinkedIn in a poll -

To what extent do you agree with the following - "In the next 5 years, AI will significantly impact both the number and type of QA/RA jobs."?

Nearly 70% of the respondents said they either somewhat or strongly agreed with the statement. (Note: this is not a scientific poll; only an indication of how our colleagues are feeling about AI)

Dear colleagues - I would love to hear your opinion. Do you see AI as a challenge or an opportunity for your career advancement in QA/RA?

Best regards

Regulatory work consist for a part of routine work (probably around 80%), part demands creative thinking (the other 20%). I think it would be possible to support the RA professionals by reducing the level of routine work, and allowing them more time for creative thinking. 

However, there is a problem. Only if you have gone through hours of routine work, ironing out all those small inconsistencies, you get to understand in depth how the separated documents in the technical documentation are interacting with each other. If we want to create automated systems that support the RA professional bridging this routine gap, we need to do some clever thinking. In the projects that I have been involved in to develop smart systems to support RA work, I brought this problem up. So far, the need to get 'something' to the market quickly got priority.

As far as I know there is nobody in the market developing a system that will really work. If you disagree with that, I guess you know where to find me.

Dear colleagues, hello! 👋

It is now clear that rapid advancement in AI/ML is transforming life around us, including the nature of work in QA/RA space.

I have been curious about this trend specifically how it is affecting the nature of our work and what it means for career advancement.

According to a recent report from McKinsey Global Institute, generative AI is poised to drive automation even in professions that involve "expertise, interaction with people, and creativity". They estimate that by 2030, automation could account for upto 30% of the hours worked in the US economy. 

Recently, I asked this question to my colleagues on LinkedIn in a poll -

To what extent do you agree with the following - "In the next 5 years, AI will significantly impact both the number and type of QA/RA jobs."?

Nearly 70% of the respondents said they either somewhat or strongly agreed with the statement. (Note: this is not a scientific poll; only an indication of how our colleagues are feeling about AI)

Dear colleagues - I would love to hear your opinion. Do you see AI as a challenge or an opportunity for your career advancement in QA/RA?

Best regards

Dear colleagues, hello! 👋

It is now clear that rapid advancement in AI/ML is transforming life around us, including the nature of work in QA/RA space.

I have been curious about this trend specifically how it is affecting the nature of our work and what it means for career advancement.

According to a recent report from McKinsey Global Institute, generative AI is poised to drive automation even in professions that involve "expertise, interaction with people, and creativity". They estimate that by 2030, automation could account for upto 30% of the hours worked in the US economy. 

Recently, I asked this question to my colleagues on LinkedIn in a poll -

To what extent do you agree with the following - "In the next 5 years, AI will significantly impact both the number and type of QA/RA jobs."?

Nearly 70% of the respondents said they either somewhat or strongly agreed with the statement. (Note: this is not a scientific poll; only an indication of how our colleagues are feeling about AI)

Dear colleagues - I would love to hear your opinion. Do you see AI as a challenge or an opportunity for your career advancement in QA/RA?

Best regards

Hi folks.

I sort of take a middle ground approach to this question.  Can AI/ML be useful for our work and profession?  Absolutely - just like it can be in any other profession.  However, I think there is a caveat we need to consider similar to the comment from Ronald - we need to ensure that we as a profession are directly involved in the programming aspects of the system because without knowledgeable individuals involved in the production of the code and plan for the work to progress there is a significant potential for inaccurate  information getting into the system and then the AI/ML "learns" information that is either not helpful or worse the information is completely wrong and then you end up with incorrect assumptions or connections that cause further problems.

Also, let's be honest - it is often difficult for more seasoned professionals to accept a new opportunity like this than it is for our more recent team members.  I think in many ways this is going to be a space where the younger members of teams are going to need to lead the charge in terms of getting this opportunity moving forward.  I completely agree that AI/ML is the wave of the future but I have also experienced AI/ML as the wave of the present in a recent job where we attempted to improve efficiency and workflow of our regulatory work using AI.  

Case study - we were working with a group in Asia (we are in the US) where we needed to get and review thousands of pages of documents to determine if they were compliant with not only the regulations but with our own internal SOP requirements.  We worked with a team to start to "teach" IBM's Watson to perform an initial review of the documents when they were sent over so that my team would get notified of the Watson recommendation when we received the email to go look at the document(s) provided.  At the time (this is about 2-3 years ago now) Watson was able to get about 45-50% of the recommendations correct for us.  That saved literally thousands of person hours in workload for the team.  We still, however, needed to go in and either validate the Watson finding manually or to override the Watson finding which would help (in theory) Watson "learn" when something was or was not acceptable based on increasing the overall dataset that Watson had access to review against.  There was a specific problem though that we could not avoid (and caused some "learning" issues for the system) - if the document was in a format that the computer could not parse out, the learning of the system defaulted to anything of that document type might be acceptable per the regulations and SOPs.  So when we went in and approved one document and rejected another in the same document format the system couldn't figure out what to do with that data.

Now, AI/ML has continued to advance in the past 2-3 years and I would assume (I have no facts or case studies to back this up!) that the systems are continually getting better at being able to manage the issue above.  However, we all know that as the world evolves and expands there will be other types of issues that arise.  Some will likely end up being similar to the situation above but there are also bound to be other situations that need to be considered, understood, and then acted upon to improve or gain the greatest possible value from these systems.

AI/ML is going to come into the regulatory world at some point.  As I said, I was involved in a project already that tried to use AI/ML to further improve efficiency.  The project was not about eliminating QA/RA jobs or anything like that - it was literally about allowing the group to be more efficient in their processes.  But if we aren't ready to become champions of the technology it is a significant risk in my opinion to the competitiveness of our companies to be left out or left behind.

Just my two cents on this one.

Dear colleagues, hello! 👋

It is now clear that rapid advancement in AI/ML is transforming life around us, including the nature of work in QA/RA space.

I have been curious about this trend specifically how it is affecting the nature of our work and what it means for career advancement.

According to a recent report from McKinsey Global Institute, generative AI is poised to drive automation even in professions that involve "expertise, interaction with people, and creativity". They estimate that by 2030, automation could account for upto 30% of the hours worked in the US economy. 

Recently, I asked this question to my colleagues on LinkedIn in a poll -

To what extent do you agree with the following - "In the next 5 years, AI will significantly impact both the number and type of QA/RA jobs."?

Nearly 70% of the respondents said they either somewhat or strongly agreed with the statement. (Note: this is not a scientific poll; only an indication of how our colleagues are feeling about AI)

Dear colleagues - I would love to hear your opinion. Do you see AI as a challenge or an opportunity for your career advancement in QA/RA?

Best regards

Dear colleagues, hello! 👋

It is now clear that rapid advancement in AI/ML is transforming life around us, including the nature of work in QA/RA space.

I have been curious about this trend specifically how it is affecting the nature of our work and what it means for career advancement.

According to a recent report from McKinsey Global Institute, generative AI is poised to drive automation even in professions that involve "expertise, interaction with people, and creativity". They estimate that by 2030, automation could account for upto 30% of the hours worked in the US economy. 

Recently, I asked this question to my colleagues on LinkedIn in a poll -

To what extent do you agree with the following - "In the next 5 years, AI will significantly impact both the number and type of QA/RA jobs."?

Nearly 70% of the respondents said they either somewhat or strongly agreed with the statement. (Note: this is not a scientific poll; only an indication of how our colleagues are feeling about AI)

Dear colleagues - I would love to hear your opinion. Do you see AI as a challenge or an opportunity for your career advancement in QA/RA?

Best regards

Agree with most comments here, i.e. 'somewhat agree' seems the predominant answer, i.e. that AI/ML will impact QA/RA work given some routine while other efforts require that 'human intelligence' touch while recognizing that   AI/ML is not always accurate and reliable..

Attended a recent event on Generative AI in Boston recently--the overwhelming conclusion was that  AI/ML will become 'smarter' and generative LLM (large language model) will have less and less 'hallucinations' in time specially when the base language model i(Open AI LLM) is trained with an enterprise's internal data like SOPs, PDF policy documents, etc. 

That said--AI/ML - regardless of how large the pre-training data is ingested will always have a predictive element to it-it isn't human thinking after all! That's the nature of machine learning until Star Trek like 'cyborgs' become real. 

We came up with a sort of hybrid solution -see videos below  and our take on this further in the attachment with DSCSA as a sample topic.

It's a hybrid app solution with  an Open AI ChatGPT-3.5 app/bot COMBINED with a full-text indexed every word on US FDA Guidance PDFs page contents from FDA.Gov on medical devices, drugs and biologics--a total of 27664 items for our search app. That said--FDA Guidance  on DSCSA are only 31 PDFs in total while supply chain references with on pharma drugs are peppered across multiple 21 CFRs!

Idea is simple--not rocket science--i.e. on the same app that runs on your mobile, laptop or browser--the app( bottom screen)  allows one  to prompt ChatGPT to discover possible search keyword hints from generative AI replies  with your prompt... BUT also allows on the app  top screen  (no externa link switching) to search full-text--and here's the rub -- you're searching the ACTUAL FDA.Gov contents collected, e.g. on DSCSA for example -i.e. you're searching full text much like Google without the web noise ads or clutter whatever the FDA has actually published on DSCSA compliance.

No one can debate that FDA is the single source of 'regulatory truth' on a topic, so if the FDA publishes it, you'll discover it. No predictive AI/ML bias here.

If you're curious--see short video recording  below.

Interested to hear anyone's feedback-but above is my 2-cents worth. 

--------------------Video  recording clips of SmartSearch+ on a Samsung Galaxy mobile phone:--------------

https://lnkd.in/g4-vchMN
 👀App integrated with OpenAI ChatGPT-3.5 Turbo Chatbot & illustrates Why US FDA  metadata or tags assigned based search is ABYSMAL!

http://tinyurl.com/278p3mwz
👀  App Sample search use case with a DSCSA stakeholder label
--find FDA Guidance or CFRs referencing  'DSCSA' with 'repacker' & 'labeling'

Dear colleagues, hello! 👋

It is now clear that rapid advancement in AI/ML is transforming life around us, including the nature of work in QA/RA space.

I have been curious about this trend specifically how it is affecting the nature of our work and what it means for career advancement.

According to a recent report from McKinsey Global Institute, generative AI is poised to drive automation even in professions that involve "expertise, interaction with people, and creativity". They estimate that by 2030, automation could account for upto 30% of the hours worked in the US economy. 

Recently, I asked this question to my colleagues on LinkedIn in a poll -

To what extent do you agree with the following - "In the next 5 years, AI will significantly impact both the number and type of QA/RA jobs."?

Nearly 70% of the respondents said they either somewhat or strongly agreed with the statement. (Note: this is not a scientific poll; only an indication of how our colleagues are feeling about AI)

Dear colleagues - I would love to hear your opinion. Do you see AI as a challenge or an opportunity for your career advancement in QA/RA?

Best regards

Hello Ram - thank you for sharing this resource. Very cool!

I am quite interested in a Smart Search type of capability for warning letters, recalls, 510Ks, PMAs etc. 

Best regards

Agree with most comments here, i.e. 'somewhat agree' seems the predominant answer, i.e. that AI/ML will impact QA/RA work given some routine while other efforts require that 'human intelligence' touch while recognizing that   AI/ML is not always accurate and reliable..

Attended a recent event on Generative AI in Boston recently--the overwhelming conclusion was that  AI/ML will become 'smarter' and generative LLM (large language model) will have less and less 'hallucinations' in time specially when the base language model i(Open AI LLM) is trained with an enterprise's internal data like SOPs, PDF policy documents, etc. 

That said--AI/ML - regardless of how large the pre-training data is ingested will always have a predictive element to it-it isn't human thinking after all! That's the nature of machine learning until Star Trek like 'cyborgs' become real. 

We came up with a sort of hybrid solution -see videos below  and our take on this further in the attachment with DSCSA as a sample topic.

It's a hybrid app solution with  an Open AI ChatGPT-3.5 app/bot COMBINED with a full-text indexed every word on US FDA Guidance PDFs page contents from FDA.Gov on medical devices, drugs and biologics--a total of 27664 items for our search app. That said--FDA Guidance  on DSCSA are only 31 PDFs in total while supply chain references with on pharma drugs are peppered across multiple 21 CFRs!

Idea is simple--not rocket science--i.e. on the same app that runs on your mobile, laptop or browser--the app( bottom screen)  allows one  to prompt ChatGPT to discover possible search keyword hints from generative AI replies  with your prompt... BUT also allows on the app  top screen  (no externa link switching) to search full-text--and here's the rub -- you're searching the ACTUAL FDA.Gov contents collected, e.g. on DSCSA for example -i.e. you're searching full text much like Google without the web noise ads or clutter whatever the FDA has actually published on DSCSA compliance.

No one can debate that FDA is the single source of 'regulatory truth' on a topic, so if the FDA publishes it, you'll discover it. No predictive AI/ML bias here.

If you're curious--see short video recording  below.

Interested to hear anyone's feedback-but above is my 2-cents worth. 

--------------------Video  recording clips of SmartSearch+ on a Samsung Galaxy mobile phone:--------------

https://lnkd.in/g4-vchMN
 👀App integrated with OpenAI ChatGPT-3.5 Turbo Chatbot & illustrates Why US FDA  metadata or tags assigned based search is ABYSMAL!

http://tinyurl.com/278p3mwz
👀  App Sample search use case with a DSCSA stakeholder label
--find FDA Guidance or CFRs referencing  'DSCSA' with 'repacker' & 'labeling'

Dear colleagues, hello! 👋

It is now clear that rapid advancement in AI/ML is transforming life around us, including the nature of work in QA/RA space.

I have been curious about this trend specifically how it is affecting the nature of our work and what it means for career advancement.

According to a recent report from McKinsey Global Institute, generative AI is poised to drive automation even in professions that involve "expertise, interaction with people, and creativity". They estimate that by 2030, automation could account for upto 30% of the hours worked in the US economy. 

Recently, I asked this question to my colleagues on LinkedIn in a poll -

To what extent do you agree with the following - "In the next 5 years, AI will significantly impact both the number and type of QA/RA jobs."?

Nearly 70% of the respondents said they either somewhat or strongly agreed with the statement. (Note: this is not a scientific poll; only an indication of how our colleagues are feeling about AI)

Dear colleagues - I would love to hear your opinion. Do you see AI as a challenge or an opportunity for your career advancement in QA/RA?

Best regards