Monitoring QM systems
- Establishing, maintaining and further developing of QM systems (ISO 15378 / IFS Food)
- Preparing and revising procedural instructions, manufacturing instructions etc.
- Introduction of document management systems
Interim management in the areas of
- Management
- Quality management
- Information security management
- Production
- Business development
- Marketing & sales
Qualification/validation
- Qualification of IT systems, laboratory devices, plants and premises
- Validation of processes in the areas of production/cleaning/laboratories
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
Training
- Establishing training systems
- Conducting staff training courses
Supplier management
- Supplier qualification
- Supplier audits
- Contract administration
System evaluations
- GAP analyses
- Preparing & accompanying of audits
- Preparing expert opinions
Accompanying of technology and product transfers
- Project management
- Process validation
- Selection of alternative manufacturers