Our Core Services
Validation Management
Development of a validation approach for a computerized
System under consideration of the customer specific quality management system
Test Management
Development of a testing approach by certified testing experts.
System Lifecycle Management
Support in all phases of the system lifecycle (Project Planning, Implementation, Operation, Retirement)
Quality Management System development
Development of a QMS according to currently valid industry standards and guidelines
Our Core Services
Validation Management
Development of a validation approach for a computerized
System under consideration of the customer specific quality management system
Test Management
Development of a testing approach by certified testing experts.
System Lifecycle Management
Support in all phases of the system lifecycle (Project Planning, Implementation, Operation, Retirement)
Quality Management System development
Development of a QMS according to currently valid industry standards and guidelines
Lifecycle Support
Our consulting services and support cover the complete software lifecycle – from initial planning to shutdown / archiving of software in a regulated environment.
Here we support with
- Development of a holistic validation approach (validation plan) taking into account corporate guidelines and best practices (GAMP, FDA Guidlines)
- Creation of requirements (user requirements)
- Selection of suitable tools / supplier selection and audits
- Documentation of technical requirements (functional and technical specifications)
- Carrying out risk analyses (risk assessments)
- Creation of a test plan
- Writing test cases
- Creation of test reports
- Migration (plan, data verification, reports)
- Traceablity Matrix
- Conclusion of a validation with a validation summary report
- Introduction to the operational business incl. SOP