DRUG REGULATORY AFFAIRS INTERNATIONAL
The WHO has just released the the final version of the important guideline “Good Data and Record Management Practices“.
We recently informed you about the WHO Draft Guidance on Good Data and Record Management Practices. Now, the WHO has just released the the final version of this important guideline “Good Data and Record Management Practices”.
The final version is sectioned rather similar to the draft version:
– Introduction
– Aims and objectives of this guidance
– Glossary
– Principles
– Quality risk management to ensure good data management
– Management governance and quality audits
– Contracted organizations, suppliers and service providers
– Training in good data and record management
– Good documentation practices
– Designing and validation systems to assure data quality and reliability
– Managing data and records throughout the data lifecycle
– Addressing data reliability issues
– References and further reading
Although the individual chapters were…
View original post 208 more words
Filed under: Uncategorized