Home

Simplify Quality, Increase Confidence

Running a successful life sciences organisation shouldn't mean constant firefighting with quality assurance. If you're struggling with repetitive deviations, audit backlogs, or outdated, paper-based processes, you're not alone. At Affirm8, we understand your challenges and are here to help resolve them.

Our clients pains

Overwhelming QMS tasks that never seem to end
Repeated deviations and complaints with no end in sight
Complexity preventing staff from following processes
New ISO standards threatening to disrupt customer confidence
Costly inefficiencies from slow, manual processes
Skill gaps within the quality organisation

About

Affirm8 Consultancy specialises in helping life sciences organisations simplify and transform their quality assurance processes. By addressing common pain points such as compliance challenges, inefficiencies, and skill gaps, Affirm8 provides tailored solutions through a proven four-step approach. From assessing risks to embedding continuous improvement, Affirm8 ensures streamlined operations, reduced costs, improved compliance, and empowered teams, enabling businesses to thrive in a competitive landscape.

Assess

Efficiently spot compliance & efficiency issues with our assessment tool, employing a RAG status approach.
Analyse

Identify key issues and implement our strategic improvement plans.
Accelerate

Remediate issues while enhancing staff knowledge and cultivating internal capabilities for future readiness.
Advance

Ongoing support ensures you stay prepared—partner with us to uphold straightforward, efficient compliance.

Feeling stressed about an upcoming GMP audit? You’re not alone! Audits can feel overwhelming, but...