Building Strong Foundations for Digital Transformation: Good Documentation and Data Integrity Practices

Overview:

Adoption and implementation of digital technologies is no longer a nice to have in the life science sector. It has become a necessity. Regulatory authorities around the world have recognized the role and benefits of going digital and have started publishing several guidelines on the same. But successful implementation and subsequent effectiveness of digital tools relies on good data management. Good documentation practices and data integrity are foundational elements for data management.

In this session, we will understand the concepts of data governance, management and integrity. We will also discuss the ALCOA principles, their practical applications and recurring regulatory observations around data integrity and technology implementation.

Learning objectives:
At the end of this session, attendees will:

• Gain a better understanding of data governance, data management and data integrity.
• Improve knowledge about the ALCOA principles & their application in both manual and electronic systems
• Identify common reasons of recurring data integrity issues.
• Learn about commonly cited data integrity & software implementation issues during inspections
•  Get actionable strategies to improve compliance.

Speaker: 

Antiksha Joshi
QMS and GMP Trainer/Facilitator