The individuality of your GxP application may require a variety of function-specific settings and measurement systems. Benefit from our know-how and let our application engineers design the optimal measuring system for you. With our consulting services in GxP, we support you from project planning (URS) to implementation and testing of your system. This ensures an optimal and efficient design.
Validation and Qualification
Validation is a process (GMP & FDA conform) of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages. Missing information and poorly specified or inadequately tested systems represent a risk and can lead to high maintenance costs and losses in productivity.
- Validation & Compliance Declaration
- Change Log
- Validation Master Plan
- User Requirements Specification
- Risk Assessment
- Requirement Traceability Matrix
- Preparation of project-related validation plans and risk analyses
- Preparation of IQ/OQ-PQ documents
- Preparation of validation reports
- And others
Mapping of warehouses, climate chambers, rooms, etc.
Incorrect climatic conditions can result in expensive damage to your products. The protection of the quality of temperature-sensitive products during transport and storage is an important and essential component of the GxP directive. The basis for observance of legal regulations is GxP-compliant qualification of the transport equipment or storage facility. We have specialized in these services and offer you an efficient solution tailored exactly to your requirements for:
- Storage rooms
- GxP clean rooms
- Fridges and freezers
- Trucks
- Shipping boxes
- & more
How do we proceed?
We discuss the modules needed for qualification with you and then develops the optimal timetable with you. Thanks to the transparent structure of the service, you only pay for the qualification steps you need.
This approach, which has proven its worth many times, is welcomed by our customers around the world. One of our qualification engineer will present the GxP-compliant data directly on customer request in the case of a possible audit.
What do you benefit from?
- Modular service structure from one provider
- Transport qualification/validation
- Temperature distribution study
- Stress tests – findings
- GDP training for handling of medicines
- Upkeep and maintenance of the overall system
- Competent support by experienced qualification engineers
- Best test equipment accuracy and competence as prestigious manufacturer of measuring instruments
What do you receive?
- Exact climate data such as temperature and humidity on the environment measured (room, vehicle, transportation box etc.)
- FDA and GxP-compliant mapping (basis for audits)
- Detailed evaluation of the data (providing information on critical areas)
Take advantage of our all-round mapping service
- Advice on compliance with official requirements
- Placement/Distribution of the calibrated Rotronic data loggers
- Evaluation and interpretation of the climatic conditions measured
- Preparation of a GxP-compliant report incl. delivery of the calibration certificates the loggers used
- A PST qualification engineer will explain and substantiate the GxP-compliant data directly on customer request in the case of a possible audit.