Data Protection and Information Security Management

Information Technology

For all topics we offer individual consultations and seminars QDC consulting

The topics of "digitalisation" and "Industry 4.0" are increasingly integrating traditional manufacturing with its machines into the IT landscape of the company.

Some existing machines and systems already have interfaces for piece counting and machine status, but new machines offer further possibilities for connection.

In order to build a future-proof system landscape and thus create a good basis for the further networking of systems, machines and infrastructure, the implementation of appropriate tools / systems is required.

Informationstechnologie qdc

This is accompanied by the ever-increasing dependency and impact of digital business processes on daily working life. Processes are (partially) automated and thus enable faster processing of activities and concentration on the essential core tasks.

We offer a view of the overall process and the associated systems in order to generate the optimum benefit and added value for the company.

From the analysis of the current situation, definition of requirements to implementation, everything from a single source.

If required, pharmaceutical-specific requirements (GxP / 21 CFR Part 11) are also taken into account in addition to the existing standards (ISO 27001 / TISAX).

Information Technology (IT)

IT Leadership

– Human Resources Management
– Strategy development / implementation
– Standardisation

IT Management

– Applications und Infrastructure
– IT Guidelines / Standards
– Supporting Tools
– IT emergency manual

IT Projekt Management

– Define requirements
– Support during implementation and commissioning
– Change Management
– Replacement of an IT system

Digitalisation of Business Processes

– Analysis of the ACTUAL processes
– Identification of digitisation potential
– Support with the digitisation

CSV – Validation of Computerised Systems

– Validation of applications
– Qualification of the supporting infrastructure
– Risked-based approach according to applicable regulations

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Data Protection and Information Security Management

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