About QualyAgent
Quality management in small pharma, biotech and food companies has always been a paradox. The regulatory requirements are the same as for large enterprises. The resources are not.
A QA manager at a 30-person pharmaceutical company is expected to maintain the same standards as a team of twenty at a global manufacturer. Write inspection-ready CAPA reports. Keep SOPs aligned with Annex 1, Annex 11 and ICH Q10. Manage deviations, change controls and supplier qualifications. Train the team. Convince production to stop when something goes wrong.
And do it all with limited time, limited budget and no one to ask for a second opinion.
We built QualyAgent because that gap is real, it is underserved, and it matters. A failed inspection does not just cost money. It can delay a product, harm a patient, or shut down a facility. Small companies deserve the same quality of support as large ones.
Sound familiar?
01
Audit Pressure
An inspection is announced. Your CAPA backlog is open, two SOPs are overdue for review, and your deviation reports do not follow the expected format.
02
Resource Gap
You are the QA manager, the trainer, the document controller, and sometimes the production supervisor. Writing a complete CAPA report takes half a day you do not have. And before you even start, you have spent two hours convincing the production team that the deviation actually needs to be investigated.
03
Regulatory Overload
Annex 1 revised, ICH Q7, ICH Q10, ISO 22000 — regulations keep evolving. How many of your SOPs are truly aligned with the current version of Annex 1? Almost no small company is fully compliant. And inspectors know it.
QualyAgent was founded by a GMP quality professional with hands-on experience in pharmaceutical and food manufacturing across Europe. Our approach combines deep regulatory knowledge with AI tools built specifically for quality documentation — not generic AI adapted for compliance, but a system designed from the ground up with GMP logic at its core.
QualyAgent is not an eQMS. It is an AI-powered document intelligence layer that works alongside your existing quality system, helping your team write better GMP documents faster.
Our Mission
To make expert-level GMP support accessible to every quality team, regardless of company size.
Book a free 20-minute call and we will walk you through the platform.