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The topic data integrity has been an integral part of numerous GMP inspections for several years. This involves ensuring and providing complete evidence that quality-relevant data from the manufacture or testing of a batch is correct and unadulterated. This is increasingly demanded also in connection with the data obtained in the automated visual inspection. Even if the systems work automatically, manual interventions and adjustments of inspection-relevant parameters such as lighting or mechanics may be necessary. To be able to prove with certainty in the case of a GMP inspection that the test data are nevertheless of integrity, a solid access management of the control system and an inspection-proof audit trail review concept are indispensable.
General requirements for data integrity
Development of a suitable access control system
Documentation of batchwise parameter adjustments in the inspection system
Concepts for an inspection-proof audit trail review
The target group of this webinar are professionals in quality assurance, technology and production who are entrusted with the implementation or operation of automatic inspection systems or their defense during audits & inspections.
Felix Krumbein, Roche Diagnostics
Felix Krumbein studied optotechnics and image processing and has been responsible responsible for the implementation of GMP-compliant imaging-tools. Now he is head of Inspections-Systems-Support at Roche Mannheim were he is responsible for the qualification of visual inspection systems.