IT Quality Management

IT Quality Management

The challenge

IT systems are the technical roadmap of complex organisations. All information in the healthcare sector from drug development, production and logistics through to patient data is processed by IT systems. The interplay of all these systems and the integration of IT in our modern organisations is a complex process. Examining complex structures across different sectors, reconciling contradictory rules (e.g. GxP demands transparency, where security requires confidentiality) – that is the challenge for modern quality management.

The solution

We will evaluate your IT systems, taking all the quality requirements that are made of you into account. This goes from data and information security right through compliant data processing and application of electronic signatures to sector-specific requirements, e.g. for systems in the finance or production areas. On this basis we will develop a basic concept for the internal design of requirements. If necessary, we will support you at the next stage to implement existing rules and develop IT services, processes and standards further through operational quality management.

This is what you can achieve:

  • GMP, GLP, GCP compliant IT systems and processes
  • Efficient processes that meet compliance requirements
  • Interdisciplinary standards and clear processes
  • Basic approaches that create transparency and save costs
  • The security of working in compliance with FDA and EMA as well as according to current standards (21 CFR part 11, SOX, GAMP 5)
  • Sustainably high quality standards thanks to an early consideration of operative processes, IT quality standards and Best Practices (ISO/IEC 20000, ITIL V3, EN ISO 9000 ff, ISO/IEC 27000 ff)

We do not depend upon special technologies but will offer you advice that is not tied to any particular manufacturer or discipline. We are familiar with the current IT systems and standards, enabling us to tailor the leanest possible approach for you in every case.

Would you like to know more about IT Quality Management? Contact our experts.