Aug 6, 2025 - 1 Min Read
About Us
Affirm8 helps life sciences teams streamline quality assurance, close compliance gaps, and drive continuous improvement through a tailored four-step approach.
The A-Grade Method
- Activate
- Assess
- Affirm
- Accelerate
- Advance
Quantifiable Results
- Reduce overdue deviations from 55% to 5% in three months.
- Increase operational quality* from 65% to 99.8% in 12 months.
How we work
The A‑Grade Method. A five-step cultural transformation process that builds momentum, sharpens quality, and sustains results.
Activate
Align teams on purpose, urgency, and possibility. Spark momentum through cultural friction diagnostics.
Assess
Deep-dive into deviation, CAPA, and QMS trends. Uncover the true roots of lagging quality performance.
Affirm
Identify wins, strengths, and existing good practices to amplify. Build confidence before correcting.
Accelerate
Run guided 90-day sprints to improve quality culture and reduce deviation backlogs with momentum.
Advance
Sustain results through habit architecture, leadership enablement, and continuous learning systems.
Testimonials
Trusted by Businesses, Proven by Results
I had the privilege of working with Affirm8, I cannot recommend them highly enough. Craig is an exceptional quality assurance professional whose expertise spans Pharmaceuticals, In Vitro Diagnostics, Medical Devices, and Cosmetics. His ability to simplify complex quality processes and drive tangible results is unmatched.
Steve
Production manager, BBI Solutions
I had the privilege of working with Affirm8, I cannot recommend them highly enough. Craig is an exceptional quality assurance professional whose expertise spans Pharmaceuticals, In Vitro Diagnostics, Medical Devices, and Cosmetics. His ability to simplify complex quality processes and drive tangible results is unmatched.
Steve
Production manager, BBI Solutions
I had the privilege of working with Affirm8, I cannot recommend them highly enough. Craig is an exceptional quality assurance professional whose expertise spans Pharmaceuticals, In Vitro Diagnostics, Medical Devices, and Cosmetics. His ability to simplify complex quality processes and drive tangible results is unmatched.
Steve
Production manager, BBI Solutions
I had the privilege of working with Affirm8, I cannot recommend them highly enough. Craig is an exceptional quality assurance professional whose expertise spans Pharmaceuticals, In Vitro Diagnostics, Medical Devices, and Cosmetics. His ability to simplify complex quality processes and drive tangible results is unmatched.
Steve
Production manager, BBI Solutions
I had the privilege of working with Affirm8, I cannot recommend them highly enough. Craig is an exceptional quality assurance professional whose expertise spans Pharmaceuticals, In Vitro Diagnostics, Medical Devices, and Cosmetics. His ability to simplify complex quality processes and drive tangible results is unmatched.
Steve
Production manager, BBI Solutions
I had the privilege of working with Affirm8, I cannot recommend them highly enough. Craig is an exceptional quality assurance professional whose expertise spans Pharmaceuticals, In Vitro Diagnostics, Medical Devices, and Cosmetics. His ability to simplify complex quality processes and drive tangible results is unmatched.
Steve
Production manager, BBI Solutions
From audit chaos to audit confidence in 90 days
If you're still scrambling before every inspection, your system isn't in control - your people are in survival mode.
We embed the habits, rhythms and ownership your team needs to stay ready every day, not just audit day.
Contact Us
We're here to help you simplify compliance, strengthen systems, and build momentum. Reach out to start the conversation.
Some of our happy clients
