EU GMP Annex 1 Compliance: Global Requirements & PIC/S Alignment
The 2023 revision of EU GMP Annex 1 reset the global standard for sterile manufacturing. It expands the guidance, tightens contamination-control expectations and aligns requirements...
Read MoreWINDSOR FRAMEWORK: WHAT IS IT?
The Windsor Framework (WF), which came into effect on January 1, 2025, is a significant agreement between the UK and the EU that replaces the...
Read MoreCAI Appoints Jamie Robertson as Vice President of Mission Critical to Drive Innovation and Operational Excellence Across Global Infrastructure Projects
August 11, 2025 – Indianapolis, IN — CAI, a global leader in operational readiness and excellence for high-stakes, regulated environments, is proud to announce the...
Read MoreUnderstanding cGMPs for Phase 1 Investigational Drugs
In 2008, the FDA issued guidance exempting most Phase 1 investigational drugs from the full scope of Title 21 of the Code of Federal Regulations...
Read MoreBalancing Scalability, Speed, and Quality in Pharma Startups
Pharmaceutical companies today face a high-stakes equation: launch faster, meet global demand, and maintain quality and compliance—without fail. That means simultaneously spinning up manufacturing sites,...
Read MoreNavigating Regulatory Complexity in Life Sciences: Turning Compliance into a Strategic Advantage
As global regulations continue to evolve, life sciences companies are facing increasing pressure to meet stringent compliance requirements without slowing down innovation or compromising product...
Read MoreA Path to Readiness Maturity: Five Phases Toward Operational Readiness
Operational readiness is not achieved overnight. It’s developed through deliberate progression across key operational domains. An organization’s readiness maturity reflects how effectively it aligns its...
Read MoreThe Pillars of Readiness: Building Toward Day One Success
Operational readiness isn’t a milestone. It’s a condition, a designed state that ensures your facility starts up safely, on time, on budget, and at intended...
Read MoreCAI and phData Forge Strategic Partnership to Accelerate AI-Driven Operational Readiness in Life Sciences
Indianapolis, IN — July 3, 2025 — CAI, a global professional services firm renowned for Operational Readiness and Operational Excellence, today announced a strategic partnership...
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