Pharmaceutical Data Integrity : ALCOA and ALCOA+

Data is an invaluable asset for pharmaceutical firms, only if its integrity is well preserved. In pharmaceutical manufacturing, production lines generate a multitude of heterogeneous data sets at different stages of medicine production. The integrity of these data sets is, therefore, critical for ensuring end-to-end traceability. Lack of good data integrity practices impacts the quality and reliability of records, ultimately affecting the quality of pharmaceutical products.

Upon completion of this course you’ll be able to:

• Explain the following concepts related to data integrity and ALCOA, compliant data characteristics, regulatory expectations for data integrity and data control, fundamentals of ALCOA.
• Assure data integrity in your organization

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

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