GxP-Services for compliance right from the start

The path to compliance with all applicable regulatory requirements and documented evidence that the system is fit for its intended use begins during the planning phase.

With our GxP-Services and GxP-Consulting we contribute to:

  • reducing your effort to achieve and maintain compliance

  • early identify potential failures and risks, and to establish corrective measures

  • benefit from new techniques and innovations

  • establish effective and smart procedures for change management and configuration management

  • procedures to assure cost-effective operation and maintenance

Our life cycle and project management approach is based on GAMP 5 guide, while at the same time it is compatible with quality system standards and other software development methodologies.

We are offering GxP-solutions and services for all life cycle phases of computerized systems, including:

  • customized validation concepts

  • comprehensive services within the development life cycle

  • establishing procedures and processes for the compliant operation and maintenance of systems

  • concepts for modernization, migration and decommissioning / data migration under GxP-requirements