Will this work with the systems we already use?
Yes. I build on top of your ERP, quality management system and maintenance software, for example SAP, Veeva or MasterControl, plus the sensor and historian data you already collect. Where a system has an API or integration, I connect to it directly. Where it does not, we use exports or controlled shared folders. Your validated systems stay as they are.
Does AI make quality or release decisions?
No. AI supports, but never replaces, QA release decisions, GMP sign-off or regulatory judgement. It flags possible defects, pre-checks batch records and drafts deviations, SOPs and reports, and a qualified person reviews and approves every one. Final batch release, investigations and anything submitted to a regulator stay with your quality and regulatory teams.
How does this fit with GMP and computer system validation?
Any workflow that touches GMP records is scoped with your quality team first. We agree its intended use, risk level and how it will be validated, in line with your existing validation approach and guidance such as GAMP 5 or 21 CFR Part 11 where they apply. Audit trails, access control and change control are built in from the start.
How do you handle data protection and security?
Production, quality and supplier data often includes trade secrets, so it stays in your own systems wherever possible. Before building, we settle what the AI can access, where data is stored and processed, including data residency, and how long it is kept. Access is limited by role and logged, and your data is not used to train public models.
Do we need new sensors or equipment?
Not always. Many sites already collect enough data in their maintenance system, historian or line controllers to start. If a critical machine has no monitoring, low-cost vibration or temperature sensors can be added later. I usually start with the data you have on one line, then we decide together whether extra sensors are worth it.
Do I need to be technical?
No. I set everything up, connect the systems and show your team how it works. Day to day, QA, engineering and production staff review drafts, act on alerts and read the morning dashboard, using tools they already know. If something needs changing, like a new alert threshold or report format, you tell me in plain language and I update it.
How long does it take, and what does it cost?
It depends on your tools, the size of your site and the use cases you start with, plus any validation your quality team needs. A first workflow, such as deviation drafts or maintenance alerts on one line, can often be running within a few weeks. A short call gives you a clear scope, timeline and price for the first step.
