Qualification/validation
- Qualification of laboratory devices, production equipment and industrial plants
- Computer validation of process control systems
Data integrity (DI) and IT security
- GAP analyses and risk assessments
- Identification of critical electronic records
- Data mapping
- Establishing of data integrity infrastructures
- Support in implementing the requirements for IT security according to ISO 27001/ BSI-Standards
- Conducting training on data integrity and information security issues
Monitoring QM systems
- Establishing, maintaining and further developing of QM systems
- Preparing and revising of SOPs and instructions
- Introduction of document management systems
Supplier management
- Supplier qualification
- Auditing
- Preparation of technical agreements
Training
- Establishing training systems
- Conducting staff training courses
Interim management
- Quality management
- Information security management
- Production
- Business development
- Marketing & sales