Monitoring quality systems
- Establishing, maintaining and further developing of QM systems
(GMP, 21 CFR, ISO 13485, ISO 9001, ISO 15378, ISO 27001) - GAP analyses
- Deviation management incl. root cause analysis
- Change processes/change management and CAPAs
- Preparation of Product Quality Reviews (PQRs)
- Preparation, execution and follow-up of audits & self-inspections
- Preparing & accompanying of authority inspections
- Accompanying of technology and product transfers
Qualification/validation
- Validation of processes in the areas of production/cleaning/laboratories
- Qualification of plants and premises
- Qualification of laboratory devices
- Computer validation e.g. enterprise ressource planning systems (ERP) and process control systems
Supplier management
- Supplier qualification
- Auditing
- Preparation of technical agreements
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
Document management
- Preparing and revising of GMP documents such as Site Master Files, SOPs or manufacturing instructions
- Introduction of document management systems
Training
- Establishing training systems
- Conducting staff training courses