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TTMS Lublin Team

Piotr Zawadzki

Quality Management Team Manager

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TTMS Quality is a „3D” 3Q service

Q1

Validations

Validation is a service of consulting and strategic supervision over CSV activities. We prepare and verify CSV products, and we are responsible for planning, rationalization and reporting of the validation approach both in projects and in the operational phase of automatic and IT systems.

Q2

Qualifications

During the qualification process, we provide documented evidence and demonstrate that the system operates in accordance with the established parameters and quality requirements. Qualification is a component of validation, i.e. the qualification is to confirm that the devices, installations, systems or rooms have been designed and made and that they function in accordance with the design, URS, specifications, standards and that they are suitable for the implementation of planned processes. This applies to both production equipment and IT infrastructure. Qualification is the first stage of validation.

Q3

Safe IT processes

The qualification of the infrastructure consists in ensuring the highest quality of IT systems operation and the organization using IT systems. During qualification, the general approach, standards and procedures of existing and new components are developed. In order to manage an effective IT organization, it is necessary to establish well-defined IT processes and the way in which IT manages new parameters, e.g. performance, software versions or security. The overall goal of the service is to build a technical, procedural and strategic framework compliant with compliance regulations (FDA, GDPR, SOX) to ensure the legal and ethical integrity of the company.

How can we help you?

Validation of computerized systems

• Software validation
• Integrity data
• Software quality management
• Maintaining a validated state

Qualification – technical validation

• Qualification of installations and process media
• Qualification of laboratory installations
• Qualification of premises, production and laboratory equipment
• Validation of the production process, analytical methods, qualification of the washing process
• Validation of medical devices
• Maintaining a validated state

Safe IT processes

• Comprehensive quality management in matrix and integrated IT (TQM)
• Just-in-time (JIT) services, increasing service speed and delivery
• Simplification of IT organization processes (e.g. Lean concept)
• Building IT oriented at internal and external clients
• Operation cost management, IT management decentralization
• Process redefinition (reengineering)
• IT project / program management

Quality management in the area of data processing in medicine

• Operational analytics and optimization
• Data mining and data integration
• BI solutions and data warehouses
• Historical data migration

Development of software in the field of medicine

• We model IT processes and manage the quality of processed data
• We develop software in the medical industry
• We implement methods such as KAIZEN, 5S, FMEA (Failure Mode and Effects Analysis), QFD (Quality Function Deployment), or SixSigma
• We operate based on ISO 9001 standards and in the spirit of the TQM (Total Quality Management) concept
• Software validation
• Integrity data
• Software quality management
• Maintaining a validated state
• Qualification of installations and process media
• Qualification of laboratory installations
• Qualification of premises, production and laboratory equipment
• Validation of the production process, analytical methods, qualification of the washing process
• Validation of medical devices
• Maintaining a validated state

• Comprehensive quality management in matrix and integrated IT (TQM)
• Just-in-time (JIT) services, increasing service speed and delivery
• Simplification of IT organization processes (e.g. Lean concept)
• Building IT oriented at internal and external clients
• Operation cost management, IT management decentralization
• Process redefinition (reengineering)
• IT project / program management
• Operational analytics and optimization
• Data mining and data integration
• BI solutions and data warehouses
• Historical data migration
• We model IT processes and manage the quality of processed data
• We develop software in the medical industry
• We implement methods such as KAIZEN, 5S, FMEA (Failure Mode and Effects Analysis), QFD (Quality Function Deployment), or SixSigma
• We operate based on ISO 9001 standards and in the spirit of the TQM (Total Quality Management) concept

How do we work

Meet the experts responsible for our validation projects. Find out what design challenges they face on a daily basis and how they solve even the most complex problems.

We are licensed for… a quality

In order to participate in projects from various sectors, we must regularly renew or obtain unique certificates due to customer requirements.

Contact us!

We are at your disposal

Piotr Zawadzki

Head of the Quality
Management Team