Alongside validation, risk-based qualification is a central element of quality assurance in GxP-regulated industries, such as the pharmaceutical industry or medical technology. From the qualification of individual devices to the qualification and validation of complex plants, GMP upgrades or new construction projects in the compliance area, Testo Industrial Services offers you the necessary manpower, the know-how and the appropriate measurement technology individually and according to your needs.
Qualification - ensuring high quality in a GMP-compliant manner
Risk-based qualification is the documented proof that a facility/room is suitable for the intended purpose and complies with regulations and standards. Quality risk management (QRM) can be used to control and monitor all measures for controlling quality risks.
We would be happy to give you a detailed insight into risk-based qualification. Arrange an individual presentation appointment with our qualification experts today.
Our service for you:
- Support from individual measurements to project management
- Design and consulting for risk-based planning and qualification of cleanrooms, plants and utilities, equipment as well as transport systems and storage areas
- Qualification support across all qualification phases - DQ, IQ, OQ and PQ
- Establishment of risk management and implementation of risk analyses
- Preparation of the qualification documents and reports
- Carrying out all qualification tests and measurements
- Complete coordination of your project
- Training your employees in practical seminars and workshops
- We share our practice-oriented expert knowledge and know-how with you
Safety and compliance for your cleanrooms
Qualification of plants & utilities
Ensures process stability and robustness
Transport and storage qualification
GxP services for storage areas, packaging and transport systems
Your advantage: Our competence
- Expertise: Consulting, measurements, project management - our industry-experienced team supports you precisely & in line with your needs
- Technology: The use of our measuring equipment with more than 4,500 references ensures reliable measurement and test results.
- Documentation: We hand over the documentation in the audit-proven layout or individually according to customer requirements to you personally on completion of the order.
In order to ensure the overall goal of patient safety, potential defects and hazards to product quality must be identified and brought under control. For this purpose, it is advisable to establish a comprehensive process of risk assessment, control and monitoring throughout the product life cycle.
We have been intensively involved in risk analysis and risk management for many years and know your requirements exactly. Our industry experienced GxP-Services Team supports you in identifying weak points and risks with regard to product quality and patient safety, as well as in defining control measures and implementing them in the course of qualification and validation. Together we optimise your quality risk management.
This is how we support you in your quality risk management:
- Structuring and planning of compliance activities for sound risk management according to ICH Q9/EU-GMP Part III
- Integration of all project participants in the risk management process
- Structuring, preparation and moderation of risk analyses according to established methods (e.g. FMEA)
- Advice & support for the implementation of a risk management strategy
Professional competence, experience and high-precision equipment. The engineers and technicians of our GxP-Services Team are on duty for you throughout Europe.
Take advantage of the professional expertise of our engineers and technicians! Arrange a non-binding consultation appointment for your qualification project today:
GxP services made to measure
More service, more security for your GxP compliance. Full service and know-how for your requirements.
We support you in your projects and are committed to your goals. Here you will find an excerpt from the references of our successful GMP projects.
Losan Pharma GmbH
Full service support: cleanroom qualification and calibration
Paul Hartmann AG
New clean room construction: Project support & qualification
Solids production: Qualification of a tablet line
Testo Industrial Services brings both the necessary metrological and regulatory know-how as well as a lived customer orientation, so that we have already relied on this support in the area of qualification and calibration for over 10 years. Thanks to the permanent deployment of experts from Testo Industrial Services at Losan in Neuchâtel, we enjoy the highest level of security with regard to compliance requirements with low coordination efforts and transparent processes.Magdalena Zakowski
Head of Equipment Management
Losan Pharma GmbH
In our Knowledge-Centre you will find answers from our experts to numerous questions about qualification. For example:
- What is the difference between qualification and validation?
- What are the qualification phases?
- What are the objectives of quality risk management according to ICH Q9?
Discover our comprehensive service portfolio. At Testo Industrial services you can obtain all GxP-relevant services from a single source.