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Software
About this product Control your production-related QM processes such as complaints with our digital workflows. Our integrated solutions run your previously paper-based process completely digitally, from entry to completion. The workflow system automatically forwards the digital form to the next instance, and reminder and escalation management takes effect if the time is exceeded. Of course, a substitute regulation is also included for task routing. Some features of complaint management: - Deposit of affected products/batch and their properties - Evaluation of laboratory results - Ad hoc reviews - Parallel and serial task dispatch - Adding documents such as digital photos to your complaint form - Automatic PDF creation and filing of the form in the eDMS after each step - Logging of activities in the audit trail - Optional return line in the process - Initiation of the individual tasks for further processing of the process - Integrated representative regulation - Distribution list for planning, processing and approval of the measures - Referencing the master data from your ERP system - Escalation messages both within the system and via email Which regulations have to be observed during the complaint process? - ISO 9001:2015, Chapter 5.1.2 - EU GMP Guide Part 1, Chapter 8 - EU GMP Guide Part 2, Section 15 - FDA 21 CFR Part 211 - FDA 21 CFR 7 Subpart C - Drug and Active Ingredient Manufacturing Ordinance (AMWHV) §19
Hamburg, Deutschland
Software
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