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Developing Effective Procedures

Needing to develop or update your procedures? Are you sitting at your computer starting to write procedures for every subject discussed in regulations and standards, addressing each statement with a procedural step? Put the procedure template away. The first step to writing effective procedures is in understanding WHY you are writing that procedure.

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Blog

Planning for a Talented Workforce: Building a Staffing Plan for New or Expanding GMP Facilities

Let’s contrast two very real scenarios: You are responsible for bringing a new GMP facility or line to full-scale production. Your board or shareholders expect you to have thought of everything that requires funding without excessive capital or operational budget overrun.

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Case Study

Performance Dashboards Development

A biotech company, preparing to launch its first drug batches, needed to implement performance measurement. CAI's global team helped identify key KPIs and built a two-level dashboard for tracking, analyzing, and reviewing results, ensuring alignment with site objectives before commercial production began.

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Digital Validation for Emerging Life Sciences Companies: Why the Time to Transform Is Earlier Than Ever

January 16, 2026

The life sciences sector continues to evolve at a rapid pace, driven by accelerated development timelines, heightened regulatory expectations and increasing pressure to operationalize quality from the earliest...

Blog

Achieving Operational Excellence in the Pharmaceutical Industry Through Program Management

January 14, 2026

Achieving operational excellence in pharmaceutical manufacturing requires Program Managers who can align communication across multiple departments and disciplines. They serve as a central point...

Blog

Digital Twins: The Gateway to Digital Transformation and Operational Readiness in Biopharmaceutical Manufacturing

December 18, 2025

The biopharmaceutical industry is evolving rapidly as manufacturers pursue greater speed, quality and reliability. A central driver of this change is the digital twin...

Organizational Readiness

December 9, 2025

The FDA Just Flipped the Switch on Agentic AI – And CAI is Ready!

December 3, 2025

How digital regulation will reshape quality, compliance and operational expectations across the life sciences ecosystem. Written by: Cassidy Reid & Alice Redmond A Regulator...

Blog

Chromatography in Biologics Manufacturing: Purification Science, Resin Applications, and System Qualification

November 14, 2025

Chromatography in Biologics Manufacturing: Science, Purpose, and Resin Applications Chromatography is a critical purification technique used in many evolving fields of biologics manufacturing including...

Case Study

GMP MANUFACTURING CYCLE TIME REDUCTION

November 13, 2025

Blog

From Day One Success to Everyday Improvement: The OR → OE Continuum

November 12, 2025

Written by Paige Kane, PhD, CPIP If you work in Life Sciences, you know that it is a complex, high-stakes operation. I’ve been through...

E-Publication

CAI Workforce & Human Performance Services

October 20, 2025

The primary organizational resource that is not readily duplicated by a competitor is the company’s employees. Due to the level of variability and unpredictability,...

E-Publication

Quality Advancement Data Sheet

September 30, 2025

Learn how structured deviation management, audit-ready documentation and digital integration deliver measurable quality improvements and reliability for life sciences teams....