Pharmaceutical Data Integrity : ALCOA and ALCOA+

Data integrity is essential to ensuring the accuracy, reliability, and traceability of pharmaceutical records throughout the product lifecycle. Regulatory authorities expect companies to maintain complete, consistent, and trustworthy data to support product quality, patient safety, and compliance. Poor data integrity can lead to regulatory findings, product recalls, and loss of trust.

Developed by Regulatory Affairs experts with qualifications from Northeastern University, Boston, the course combines theory and real-world application to help professionals understand and implement compliant data management practices.

Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

✅ Who should enroll?

• Quality assurance and quality control professionals
• Manufacturing, production, and laboratory personnel
• Regulatory affairs and compliance specialists
• Professionals responsible for GMP documentation and data management

 
🎯 What you’ll learn?

• Principles of data integrity and regulatory expectations (FDA, WHO, MHRA)
• Apply ALCOA and ALCOA+ principles to ensure compliant records
• Identify and prevent common data integrity violations
• Ensure data integrity across paper-based and computerized systems

Curriculum:

 
Introduction

• Why is Data Integrity Important in Pharmaceuticals?
• Who is responsible for ensuring Data Integrity?

Lesson 1: Overview of data integrity guidance

Lesson 2: Principles of data integrity

Lesson 3: ALCOA Principles for Data Integrity

Lesson 4: Data integrity violations

• Common issues
• Addressing violations

Lesson 5: How to assure data integrity ?

• Quality Culture
• Data Life Cycle Management

Lesson 6: Data Integrity for Paper-Based Systems

Lesson 7: Data Integrity for Computerized Systems

Lesson 8: Role of Quality System in Data Integrity

Conclusion

Glossary

Quiz