Reduce overdue deviations from 55% to 5% in 90 days.

Affirm8 played a pivotal role in strengthening our quality culture at BBI. Within just 90 days, they introduced action adherence metrics that brought real accountability to our team. As a result, our QMS compliance rate increased from 48% to an impressive 98%. This transformation has made a significant difference to our quality operations. A huge thank you to the entire Affirm8 team.

During 2San’s scale-up phase, we set ourselves the challenge of achieving ISO 9001 certification within 90 days without disrupting day-to-day operations. Thanks to Craig at Affirm8, we had a fully documented quality management system and a clear implementation plan in place on time. His expertise made certification both achievable and straightforward.

We are now prioritising our resources into the supplier oversight, where it is needed based on our new risk assessment process, which before we were not doing.

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.