By Michael Sassano, Founder, Chairman GR, Interim CEO of SOMAÍ Pharmaceuticals
The third part of the series. How to use AI in Quality, Regulatory, Legal, and IT Security.
Your cool AI tool is not important to the regulators. This line was the first in this series and it is important everywhere. A human signature is required by law in the following functions: Quality, Regulatory Affairs and Legal, as well as IT Security. AI can still be useful. AI watches, organizes and drafts. A named person reviews and signs.
The compliance department is the backbone of any business. When you do it correctly, all other departments will be able to move more quickly because they have current paperwork.
Quality: Staffing the Documentation Engine
Why would a person spend an afternoon reformatting deviation reports when AI will have the first draft available before the meeting begins? Quality can be staffed with four AI agents. However, this is still the only function that relies on existing systems and not a standalone app.
- The Drafting Agency Claude or Copilot will turn a set of rough notes into a SOP, checklist, or deviation summary within minutes. It won’t replace your quality system, but will clear the blank page quicker than a junior analyst.
- The Agent for Deviation and CAPA. AI features built into platforms like Veeva VaultQMS or MasterControl summarize deviations, identify patterns in CAPAs and flag those that are trending towards a repeat issue before it happens.
- The Audit Readiness Agent AI will compare your SOPs to your last audit results and show you the gaps. This is a second set of eyes which never tires before an inspection.
- Trend Watching Agent You can ask AI what the trend is by pointing it at your quality data. It is better to catch a slow-moving trend early than one that moves quickly.
Start with the next SOP you want to rewrite, and give AI your messy first draft. It will clean up the structure and language. Then you can go through it line-by-line. Your signature remains yours. The blank page is not required.
Staffing the Multi-Country Filing Desk
In reality, a regulatory team that tracks filings at half a dozen agencies runs a small logistical operation. The AI can be very useful in this case, but you should admit that the majority of serious tools are still located within enterprise regulatory information systems and not something you could log into yourself.
- The filing draft agent. Claude and Copilot can transform your technical files into a narrative first draft for BfArM Infarmed or MHRA. You will save hours by avoiding repetitive formatting.
- The Deadline tracking agent. Enterprise platforms such as IQVIA’s regulatory information management tool and Certara’s regulatory intelligence tool track renewal dates automatically across jurisdictions, so that nothing lapses just because someone went on vacation.
- The Change Monitoring agent. When you paste the latest circular, ask AI to summarize updates to that agency’s guidance. This will not replace the need to subscribe directly to the regulator, but it can turn a long document into three sentences that you can use.
Build a simple repository that contains all of the documents you’ve filed this year. This can be done agency by agency. You can then ask AI to create the renewal calendar for next quarter. This alone eliminates the biggest cause of regulatory near-misses: forgetting dates.
Legal: Staffing the First Pass Review Desk
AI is most advanced in the legal field, where contracts are the best type of document for AI to read. Contracts are structured and repetitive documents that AI understands the best.
- The Contract Drafting Agent Spellbook is a Microsoft Word add-in that drafts or redlines your contract language using your house style. The first version of the program has already been completed.
- The Contract Review Agent LegalOn will check an incoming agreement against your standard contract and highlight any clauses that do not match your terms.
- The Contract Lifecycle Manager. Ironclad and Juro will keep all NDAs and vendor agreements organized from draft to final signature so that no one has to dig through emails for the final version.
Before you send out your next NDA, run it through an agent of review. The lawyer will still sign off. The first run is just getting faster.
IT Security and GDPR Staffing: A Watchtower
The GDPR gives real weight to data about patients and prescribers. Small teams and individuals can use AI tools in this area.
- The Compliance Monitoring Agent. Vanta and Drata will continuously test your systems for compliance with GDPR and security guidelines and automatically collect evidence, rather than someone manually assembling a file once a year.
- The Data Mapping Agent. OneTrust helps you find where your personal data is stored across all of your systems. It also automates responses when someone asks about the data that you have on them.
- The Breach Watch Agent. The same monitoring tools flag up unusual access patterns when they occur, so that the data protection officer is notified of a problem within minutes and not weeks.
Connect a monitoring agent this week to a single system, no matter how small. The best way to monitor a system is to do it well.
The Common Thread
In this article, each agent does the exact same thing in a completely different outfit. It tracks, drafts and watches. The human named in the name still reviews and signs because this is what law actually requires.
Start by focusing on the desk where you have spent the most time this month. Start with one agent, and then expand.
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You can read the first part of this series by clicking on the link below.
Read Part 2 by clicking on the link below.
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