On the solid foundation of a Quality Management Design we build and execute the compliance strategy. The focus of our Q-Experts is always on controlling quality risks and guaranteeing product safety during development, production and distribution.
Our experts plan and optimize your quality issues by validating your processes, procedures, applications and equipment. With the right documentation and a strict execution, we are able to work efficiently and avoid errors.
These are the areas in which we are specialized.
Management Responsibility
- Facilitate Quality Risk Management Exercises
- Issuance and follow-up of CAPA’s
- Issuance and follow-up of change controls
Resources
- Facilities and Equipment Qualification Activities
- Computerized Systems Validation
- Lab Equipment Qualification Activities
- Issuance of Quality Agreements
Product Realization
- Process Validation in product process
- Process Validation in supporting processes (sterilization, cleaning)
- Method Validation Activities
- Technology Transfer Activities
Evaluation
- Perform deviation and complaint investigations and issuance of stability protocols/reports and Perform data trending
- Perform Quality/Compliance audits
- Technical writing of SOPs / WI’s
- Roll-out of involved IT-systems involved in Quality Management as DMS-LMS-QTS
