Resource Center

FEATURED

E-Publication

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.

Read more >

FEATURED

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.

Read more >

FEATURED

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.

Read more >

Filter By:

View As:

Content type

Resouce type

E-Publication

Case Study

Blog

Topic

Compliance & Regulatory Issues

Project Management & Scheduling

Operational Readiness & Excellence

Digital Transformation & Harmonization

Resource & Staffing Challenges

Quality, Compliance & Regulatory

AI & Advanced Technologies

Global Site Launches

Strategy Leadership

Execution Excellence

Quality Advancement

Workforce Capability

Equipment & Facility Readiness

Digital & Data Maturity

Data & Digital Enablement

Qualification and Validation

Compliance, Analytics, Data Infrastructure

Automation and Information Technologies, Database, CQV

Services, Human Performance, Training

Process & Manufacturing Technology, Tech Transfer

Artificial Intelligence

Asset Management and Reliability, Asset Performance Management, M&R, Maintenance Engineer, Spare Parts, Maintenance & Reliability, inventory

Asset Management and Reliability, Maintenance Engineer, Spare Parts, Maintenance & Reliability, Maintenance

GENERAL, Qualification and Validation, Risk-Based Approach, CQV, Quality

Automation, Automation and Information Technologies, Data Integrity, Computer Systems

Asset Management and Reliability, Asset Performance Management, M&R, Spare Parts, Maintenance & Reliability, Maintenance, inventory

Asset Management and Reliability, Asset Performance Management, Maintenance Engineer, Spare Parts, Maintenance & Reliability, Maintenance, Database, Quality, inventory, Training

Building & Facilities Management, Capital Investment Project, Compliance, Building Commissioning, Safety

Qualification and Validation, Asset Performance Management

Commissioning and Sustainability, Building Commissioning, Data Centers

Operations and Regulatory Consulting, Compliance, Regulatory

Operations and Regulatory Consulting, INDUSTRY, Risk-Based Approach, Quality, Compliance, GMP, Regulatory

Operations and Regulatory Consulting, INDUSTRY, Quality, Compliance, GMP, Regulatory

Human Performance, Training, Project Management

GENERAL

Human Performance, Owner's Project Management, Project Management, Program Management

Qualification and Validation, CQV, GMP, Project Management, Program Management

Operations and Regulatory Consulting, Quality, Compliance, GMP, Regulatory

Start-UP Companies, Compliance, GMP, Regulatory

Qualification and Validation, Risk-Based Approach, CQV, Compliance

Operations and Regulatory Consulting, Quality, Compliance, Regulatory

Asset Management and Reliability, Asset Performance Management, M&R, Maintenance Engineer, Spare Parts, Maintenance & Reliability, Maintenance, inventory

Owner's Project Management, Project Management, Program Management

GENERAL, Qualification and Validation, Enhanced Design Review, CQV

Qualification and Validation, Risk-Based Approach, CQV

GENERAL, Owner's Project Management

Commissioning and Sustainability, Data Centers

Building & Facilities Management, Commissioning and Sustainability, Capital Investment Project, Owner's Project Management, Building Commissioning

Chemistry of Full Scale Operations, Start-UP Companies, OPM, Quality

Automation and Information Technologies, Serialization

Asset Management and Reliability, Asset Performance Management, Chemistry of Full Scale Operations

Qualification and Validation, FAT, Factory Acceptance Test, CQV

Automation, Maintenance & Reliability, Maintenance, Human Performance, Training

Automation and Information Technologies, Database

Asset Management and Reliability, M&R, Spare Parts, Maintenance

Human Performance, Training

OPM, Owner's Project Management

CQV

Asset Management and Reliability, Maintenance & Reliability, Maintenance

Building & Facilities Management, Commissioning and Sustainability, Building Commissioning

Building Commissioning

GENERAL, Human Performance, Training

Quality, Compliance, Regulatory

Commissioning and Sustainability, Data Integrity, Building Commissioning

Automation, Automation and Information Technologies

Asset Management and Reliability, Asset Performance Management, Maintenance & Reliability

Building & Facilities Management, Building Commissioning

Owner's Project Management

INDUSTRY

Chemistry of Full Scale Operations

Asset Management and Reliability, Asset Performance Management, Risk-Based Approach, Maintenance

OPM, Compliance, Regulatory

Human Performance

Automation, Automation and Information Technologies, Data Integrity

Asset Management and Reliability

Maintenance & Reliability, Maintenance, inventory

Automation, Automation and Information Technologies, Serialization

Quality, Compliance, GMP, Regulatory

CMMS, M&R, Spare Parts, Maintenance & Reliability, DataVoke

M&R, Maintenance & Reliability, Maintenance

M&R, Maintenance Engineer, Maintenance & Reliability

GENERAL, INDUSTRY

INDUSTRY, Capital Investment Project

Services

Project Management

Data Centers

Press Releases

Partnerships

QMS/Med Device

cGMP

Quality Assurance

Machine Learning

Supply Chain

Life Sciences

Pharmaceutical

Biopharmaceutical

Operational Readiness

Risk Assessment

Operational Excellence

Biotechnology

Biotechnology Manufacturing

Good Manufacturing Practices (cGMP)

Data Security

Digital Transformation

Compliance trends in manufacturing

Pharmaceutical Industry

FDA Regulations

Regulatory Compliance

Innovation in Healthcare

Drug Development and Manufacturing

Artificial Intelligence in Pharma

Pharmaceutical Manufacturing

Quality Management Systems

Advanced Technologies

Large Language Models (LLMs)

Workflow Optimization

Risk Mitigation

Time-to-Market Acceleration

Emerging Technologies

Drug Development

Innovations in Life Sciences

Digital Twin Technology

Quality & Compliance

Digital Transformation in Pharma

Digital Transformation in Life Sciences

AI in Pharma

Smart Factory Strategies

Automation & Robotics

Innovation & Emerging Tech

Sort By:

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....

E-Publication

Data & Digital Enablement Data Sheet

September 30, 2025

Explore actionable solutions, practical case studies and proven outcomes showing how digital integration drives compliance, visibility and efficiency for life sciences....

Engineer with helmet and laptop inspecting HVAC system blueprint

E-Publication

Facility & Equipment Readiness Data Sheet

September 30, 2025

Strategic overview of readiness solutions, methodologies and measurable benefits for life sciences facility launches, audit, and operational alignment....

E-Publication

Execution Excellence Data Sheet

September 30, 2025

Unlock methodology, solution details and proven impact metrics for accelerating batch release, eliminating bottlenecks and minimizing risk at every stage....