Des déviations en cascade pour ce fabricant d'API indien

Les préoccupations autour de la "data integrity" ne concernent pas que les systèmes informatisés mais aussi les enregistrements "papiers" comme l'indique cette nouvelle mise en demeure :

1.    Failure to record activities at the time they are performed and destruction of original records.

Specifically, your employees completed batch production records entries days after operations had ended, released lots before the proper approvals, and failed to maintain original manufacturing data for critical steps in the batch production records...

2.    Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent omission of data.

 

Your laboratory systems lacked access controls to prevent raw data from being deleted or altered

Plus d'information ici.