From 2006 to 2018, I worked for a service company based in Berlin as a consultant and trainer for the the Empower™ software.
ITIL user support for Empower™ network installations
Creating custom calculations through reports and custom fields
Validation of computer systems according to GAMP5
Qualifying Empower™ users, administrators, and lab management, as well as training Empower™ consultants
Regular conduction of Empower™ seminars at well-known pharmaceutical companies in Germany and Switzerland
Participation in Empower™ Rollout Projects
Coaching and hands-on training
Troubleshooting of communication error for chromatographic instruments connected to Empower™ (device connection, LAC/E troubleshooting)
Insight into the Empower™ reality at numerous customers in the pharmaceutical field, from the personal workstation to the global network
2 years experience in pharmaceutical development at Eli Lilly in Hamburg
5 years experience in pharmaceutical development at Ferring Pharmaceuticals in Kiel and Copenhagen
In 2018, I started my own business as a consultant and trainer for the Empower™ software. In addition to advising and implementing all Empower ™ topics, my offer has shifted its focus to validating Empower™ installations. The offer is supplemented by the implementation of AQbD using the Fusion QbD® software, for which cromingo® officially represents the S-Matrix® Corporation in the german-speaking region and neighbored countries.
My goal is to build a long-term, co-operative relationship with my customers. Openness, commitment, trust, seriousness and real interest in the concerns of my customers are therefore a matter of course for me. Only together we can achieve the best possible results, pragmatically, but without losing sight of sustainability.
The wishes of my customers have the highest priority. My self-concept as a consultant is to give you a broader basis for decision-making, not to implement my ideas. Having all the information on an issue the customer can make the best possible decision for himself.
My self-conception as a trainer is to provide the training content in the best possible and target group specific way through didactical preparation of the covered subject matters.
The success of my clients is also my success. Let us be successful together!
You can not know or implement everything yourself. Therefore, I rely on a strong networking with other service providers, vendors and customers in the industry. The contacts I have built will be a benefit for my clients as well. Wherever it makes sense, one can also enter into strategic cooperations.
As a service and distribution partner of S-Matrix® Corporation, cromingo® offers purchase, support, training and qualification for the Fusion QbD® software in the DACH region and neighbored countries.
standardized seminars
on-site courses at customer sites
workshops and tailor-made seminars
hands-on training: coaching in everyday working life
data integrity in Empower: features and definition of data review procedures
development of training concepts
electronic signature
device control
configuration of Empower™
concept for the use of custom fields
validation concepts based on applicable regulatory guidelines (GAMP5)
development and validation of custom fields
configuration of Empower™
concept for the use of custom fields
development of training concepts
develop and build Empower operating procedures
jobs of any kind where resources with Empower™ expertise are required
creation of validation documents for the entire validation lifecycle of a computerized system
instruction & support
distributorship for Fusion QbD® (Germany, Austria, Switzerland and neighbored countries)
installation & qualification
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.
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
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
"We also appreciate your teaching skills. That's why we always like to call on you"
"We are very happy that we have you as a coach. With you we know our employees in good hands"
"I admire the angelic patience that you have with less skilled participants"
"I really enjoyed working with you. I look forward to working with you again and will be happy to recommend you"