Systems GxP, data integrity, quality, validation
GAMP 5 TRAINING – JANUARY 2021
In a perspective to always be efficient and to excel, Pharmasys organizes training sessions on validation & Data integrity of computerized systems according to the GAMP5 methodology for our new colleagues.
The objectives of this training :
- Understand and assimilate the validation guidelines applied to computerized and automated systems according to the validation methodology GAMP5 and new Data Integrity requirements
- Assimilate and apply GAMP5 concepts, ASTM E2500 approach and new Data Integrity main concepts
- Assimilate and apply the 21CFR part 11 and new Annex 11 “risk analysis” approach.
- Assimilate a “modular” approach to Validation in order to be able to define the activities and effort required to validate each automated and computerized system
- Assimilate the writing of the protocols and test sheets
We would like to thank our new recruits for their commitment, dynamism and motivation.
As part of our development, we are strengthening our teams.