New Brazilian ANVISA Guide for the Validation of Computerised Systems
Recommendation
4-6 November 2025
Copenhagen, Denmark
Including discussion on the brand new draft of EU GMP Guide Annex 22 ‚Artificial Intelligence‘.
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On 14 April 2020, the Brazilian regulatory authority ANVISA published a draft guideline for the validation of computerised systems. This guideline is to replace the previous guideline from 2010. The draft can be commented until 12 August 2020. The draft itself is only available in Portuguese.
The guide is applicable to computerised systems used in areas, equipment and other activities related to GMP. The draft of the guideline is strongly based on GAMP 5, which is specifically mentioned and partially adopted in its structure. The scope of application includes computerised systems of categories 3, 4 and 5, interfaces between systems and spreadsheets.
Structure of the ANVISA guidelines for the validation of computerised systems:
1. Scope
2. Introduction
3. Legal Basis
4. Concepts, Terms and Definitions
5. Life Cycle Approach
6. Quality Risk Management
7. Categories of Software and Hardware
8 . Inventory List
9. Validation of Computerised Systems
10. Inventory List
11. Operation of Computerised Systems
12. Data Migration
13. System Retirement
14. Validation of Spreadsheets
15. Final Considerations
16. Glossary und Acronyms
17. References
Source: ANVISA
Guia para Validação de Sistemas Computadorizados
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