AI and its capabilities are big in the news right now, and inevitably folks start asking “What will this mean for my profession.”
The pharmaceutical GxP world is inherently slow to adopt new technologies. How many of my CxOs are still using 1990s technology? All of them. However, AI/ML has been showing up in more and more places so it is good to examine the potential to the Quality profession
It may seem counter-intuitive but the first place AI-powered software is making a difference is in improving the speed, accuracy, and efficiency of document review. From the eTMF to lab results to all the forms still used on the manufacturing floor, AI is already reviewing at a rate much faster than humans (and more reliably). Expect to see these options grow and become more part of offerings, such as your eTMF.
Trending is another place where AI/ML software is more capable than humans. Basically, anything that involves analysis will eventually be done by AI software, and will be done by software. We’re already seeing more and more automation be built into COTS and we will continue to see this trend grow.
So what won’t AI take the place of in the Quality Profession. Our real value is to strategize, understand causation, be creative, empathize and use common sense.
There’s a long way to go before AI can even do the things above. Have you asked one to write a policy on use of AI in GxP? Said policy would result in no AI ever being used in the GxPs.
Here is an example of a GxP policy for the use of AI to write SAS scripts, provided by an AI:
GxP Policy for Use of AI to Write SAS Scripts
- Purpose: The purpose of this policy is to provide guidance on the use of AI to write SAS scripts in compliance with GxP regulations.
- Scope: This policy applies to all AI systems and applications used to write SAS scripts for the analysis of data subject to GxP regulations.
- Responsibilities: It is the responsibility of all employees to comply with this policy and to report any non-compliance to the appropriate management.
- Compliance with GxP Regulations: All AI systems and applications used to write SAS scripts must be designed, developed, validated, and maintained in compliance with applicable GxP regulations.
- Data Integrity: All data used by AI systems to write SAS scripts must be accurate, complete, consistent, and attributable. Data must be protected against unauthorized access or modification.
- Validation: All AI systems used to write SAS scripts must be validated to ensure that they produce accurate and reliable scripts.
- Change Control: Any changes to AI systems used to write SAS scripts must be documented and approved through a formal change control process.
- Training: All employees involved in the use of AI systems to write SAS scripts must receive appropriate training on their use and on this policy.
- Audits and Inspections: All AI systems used to write SAS scripts are subject to internal and external audits and inspections to ensure compliance with this policy and with applicable GxP regulations.
- Continuous Improvement: This policy will be reviewed regularly and updated as necessary to ensure its continued effectiveness.
Awesome. I’ll circulate this beauty for approval right away.
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