|
Consulting
|
|
- Consultancy (specific support or long term support)
- Validation review of specific product development activities
- Project quality management
- Project collaboration / realization
- Project coaching
- Support for Quality Assurance and Quality Management departments
- Regulatory compliance / e-compliance, including:
- Computerized System Validation (CSV)
- Electronic Records & Signature according to EU Annex 11 and 21 CFR Part 11 (ERES)
- Definition of e-compliance strategy
- At project level
- At corporate level
- Risk management
- Definition of system architecture
- Elaboration and review of various Qualification documents such as:
- Quality Manual, Quality Directives, Quality Policies (Quality Management System)
- Validation Master Plans
- High level SOPs
- Project respectively system specific Qualification Plan & Report
- System specific SOPs
- Specification, e.g. User Requirements Specification (URS), Functional (FS), Design and Test Specifications
- Global co-ordination of CSV activities (e.g. CH, DE, FR, JN, USA, …) for:
- GCP, GDP, GLP, GMP departments
- Elaboration and deployment of global CSV and e-compliance training concepts.
|
|
|