Quality and CSV related Services
Planta Solutions GmbH offers coaching and provides services in relevant industries
Partnerships for authentic success.
It is a key competence needed for business success in the pharmaceutical and medical device area to have procedures and documentation in place to meet these GMP requirements for passing Authority inspections needed for the approval of all these products and to stay successful in the market.
Services Overview
We are providing flexibility, based on insight, to better meet your needs.
Customer satisfaction is our main goal!
We work together with you for guaranteed results.
Result:
Robust compliant Business
We help you to install procedures to secure your business data and meet regulatory requirements in regulated industries.
Business Efficiency
- Business Process Optimization
- Data-driven Business Decision Implementation
- Transparency of Costs and Risks
- Portfolio Optimization
- Project Management
- Due Diligence Activities
Quality Systems
- Preparation of chemical/pharmaceutical GMP/GLP Inspections
- Preparation of Inspection for IT Systems in regulated Areas
- Auditing you and your Suppliers
- Gap Analysis for GMP Conformity
- Data Integrity Gap Analysis
- Validation and Qualification
- System Documentation
- Change Management Optimization
IT Quality
- Business Requirements – technical Infrastructure Match
- Computerized Systems Qualification and Validation (CSV)
- System Qualification Documentation
- System Inspection
- Risk-Based Qualification Approach
- System Training
- Mobile App Integration
- Legacy Data handling
Data Systems
- Document Management Systems
- LIMS Systems
- Application Interfaces
Documentation
- General SOP’s
- Validation and Qualification Plans and Protocols
- Test Scripts
- Device Descriptions
Chromatographic Data Systems
- Validation
- Qualification
- Installation
- Backup & Restore
- Troubleshooting
- Chromeleon™
- Laboratory Application Management
