Changes and Additions in the New Eudralex vol. 4, Chapter 4: Documentation

1. Review and update SOPs for all documentation types to reflect the changes in chapter 4 including Annex 11, Annex 22 and Chapter 6 references.
2. Consider including a Data Governance Policy in your system.
3. Embed governance, ownership, and risk assessment processes into all relevant processes in your quality system.
4. Validate hybrid system and configure electronic systems for trend analysis.
5. Update your signature policies defining when to sign manually and electronically both on a policy and practical level. 
6. Update your data integrity policy introducing ALCOA++ principles across all GMP documentation activities.

The following new chapters have been introduced: 

• Data governance systems to include QRM principles and oversee the life cycle of GMP records. 

• Risk management linked to the full life cycle of documentation with special focus on challenges with electronic data storage. 

• General requirements with special focus on hybrid systems, outsourced functions, annex 11 and annex 22. It is stressed that you are responsible for AI generated data and electronic systems must support trending. Avoid defining printed data as raw data. 

• Master Documents combine “Required GMP Documentation” and “Procedures and Records”. Validation master plan and quality agreement have been added. OOS have been separated from Deviations 

• Signature in relevant documentation again with focus on electronic systems. It is not allowed to print and manually sign documentation. It is recommended to avoid Hybrid systems, and if used, the signature form should be defined. 

• Data Integrity in documentation introducing a more risk-based approach for integrity documentation 

• Hybrid systems should be described in detail, and all elements must be validated 

• Glossary – was missing earlier make sure to align definitions given with your quality system. 

In the existing chapters especially the implementation of ALCOA++ data integrity criteria is a major change. Additionally, the section about retention of documentation have become clearer, again focusing on electronic data. As an example, it is stated that it should be in a human readable format. Additional receipt requirements, including proof of temperature compliance during transport have been added.