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