More than twenty pharmaceutical companies in Germany, Austria and Switzerland as well as in neighboring European countries now trust in cromingos' liability. It is also due to this liability that our customers are not mentioned here without their consent. Nevertheless, selected case studies should be published here in consultation with the respective customer.
Aristo Pharma GmbH (Berlin) - May 2019 - June 2020 ▼
Implementation of an Empower 3 Enterprise network - consolidation of previously independent Empower instances for four sites of the Aristo Pharma Group into a single central instance
- Workshop on current data integrity standards and concrete application to the Empower network (administration, user management, validation lifecycle concept)
- Preparation of the entire validation records according to GAMP5 rules (plans, user requirements, specifications, risk analysis, user acceptance tests, reports)
- Discussion, elaboration and construction of the Empower 3 configuration based on the specific customer requirements. (system policies, user management, project filing structure)
- Preparation of IOQ documents and supervision of the installation of the Empower 3 core system to ensure GMP-compliant implementation
- Planning and creation of all test cases to validate the Empower 3 computer system
- Conceptional planning for data migration, archiving and decommissioning of legacy systems
Medinova AG (Zürich) - June 2018 - February 2019 ▼
1. Implementation of an Empower Workgroup
- Creation of the entire validation documentation according to GAMP5 (plan, URS, specifications, risk analysis, user acceptance tests, reports)
- Configuration of Empower (Policies & User Management)
- Coordinate the implementation into the AWS Cloud
- Planning and execution of user acceptance tests
- Planning and performance of data migration
- Updating of all operational SOPs and establishment of current data integrity standards
- Knowledge transfer about GxP-compliant CSV
2. Planning and execution of a CAPA measure
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