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  • We focus on the details

    because patient safety is of the utmost importance

We offer a wide range of compliance services

to help you ensure that you never compromise patient safety and that you are always inspection-ready.

Whether we collaborate with you regarding validation, project management, management consulting or whether we provide training within data integrity and IT compliance, we always make sure to prepare you with the most precise legislative interpretations, enabling you to generate and maintain sustained competitive advantage.

Cooperation with us allows you to always deliver the highest quality and to always ensure that you are in compliance.

Plan your company’s success in collaboration with us.

Project management

Minimise internal resources and let our highly-educated consultants safely manage your projects to their conclusion

Management Consulting

Gain input for strategy and operationalisation from management consultants who have worked with the systems themselves

Validation

Let us assume responsibility for your compliance with the expectations of the public authorities and for making sure that you are always ready for inspection

Training

Ongoing education, training and knowledge sharing are critical for our ability to offer a high level of quality in everything we do

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Compliance is first and foremost about patient safety

And patient safety is primarily based on trust.
Trust that both big and small details are handled with the utmost dedication and precision.
We consider patient safety to be a very serious matter and are therefore dedicated to the details involved in validation and optimal processes in the Life Science industry.  

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Our employees are our greatest asset

The qualifications and values of our employees is the most important service we offer our customers. All are hand-picked for the job, regardless of how much experience they have accrued.

They are all driven to deliver a unique service of the highest quality, and they always strive to achieve full customer satisfaction through their personality and their performance. 

All our senior consultants have cross-functional backgrounds combined with competencies and experience within IT, risk, processes, quality assurance and compliance.

Are you our new colleague?

Join the team

Genau Talks focuses on a number of questions and tendencies within compliance in the following videos

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Recommendations working with Computerised Systems
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Current regulations within EU GMP on computer systems validation
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Anna Lundén talks about tendencies and developments to be found in observations and warning letters
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The future within EMEA on validation of computer systems.
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IT and QA are getting closer
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FDA GMP and EU GMP on hybrid systems
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Main trends within validation in general.
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Computer Systems Validation and Part 11.
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Making correct and practical best use of design qualification
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Wrong resources and attention put into wrong quality programs
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John Lee talks about data integrity, statistics and trends.
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