Felix Krumbein, Roche Diagnostics
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.
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.
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- 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
Recording from 16.05.2019
Duration of recording: 1,5 h.