Digitization

Our range of services includes:

We support you in the initial assessment of the digitization status in your company with the following steps:

  • Analysis of the current status in the context of the digitalization of your company,
  • Holistic determination of needs and requirements,
  • Interviews with stakeholders and
  • Consolidation and analysis of the results.

We work with you to determine the innovation potential and challenges in the context of digitalization in your company:

  • Identification of potential innovations in the four levels of digitalization:
    digital processes, digital products, digital business models, digital networking,
  • Identifying the necessary changes in the company and
  • Evaluation of the influence of the changes brought about by digitalization
    in the company.

We work with you to develop a suitable digitalization strategy for your company:

  • Outline an individual strategy, taking into account the objectives in the levels and dimensions of digitalization,
  • Designing your iterative roadmap for digitization and
  • Communicating your digital strategy.

We support you in the implementation of your digitalization strategy by:

  • Creation of your project plan with sequences and milestones and
  • Support in the project phases è Best practice and migration.

Our regulatory specialists team up with the digitalization experts for the:

  • Analysis of your technical documentation and development of a concept for converting the content of documents into data,
  • Development and realization of transfer projects for your technical documentation together with the relevant tool providers and
  • Support with the creation or transfer of your technical documentation to an ALM/PLM system

We work with you to digitize your processes with new systems:

  • Process optimization taking into account the relevant tools (coordinating processes and tools),
  • Development and realization of transfer projects together with the relevant tool providers and
  • Support with the creation and/or conversion of your quality management system into an eQMS.

The best digital tool is useless if it has not been validated (before its first use). We are happy to help you with this often-unpopular topic:

  • Basic training courses on computer system validation,
  • Analysis of the need for action in relation to the requirements of EN ISO 13485 and other requirements of the MDSAP countries (USA, Canada, Japan, Brazil, Australia),
  • Support with the procedural implementation of CSV in the QM system,
  • Support in identifying the IT systems in the company,
  • Creation of a validation master plan,
  • Risk assessment of the identified systems as a basis for deciding which CSV activities need to be carried out,
  • Validation of systems assessed as requiring validation according to a risk-based approach and
  • Support with auditing.