Transition Technologies Managed Services

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TTMS Quality is a „3D” 3Q service

Validations

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

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 to function in accordance with the architecture, user requirements, specifications and the correct standards, and that they are suitable for implementation of the planned processes. This applies to both production equipment and IT infrastructure. Qualification is the first stage of validation.

Safe IT processes

The qualification of the infrastructure consists in ensuring the highest quality of operation of the IT systems and of the company or organization using them. During qualification, the general approach, standards and procedures for the existing and new components are developed. In order to effectively manage an IT-reliant company, 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 in accordance with the compliance regulations (FDA, GDPR, SOX) to ensure the legal and ethical integrity of the company.

Validations

Qualifications

Safe IT processes

How can we help you?

Validation of computerized systems

Software validation
Data integrity
Software quality management
Maintaining a validated state

Qualification - technical validation

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

Safe IT processes

Comprehensive quality management in matrix/integrated IT (TQM)
Just-in-time (JIT) services, increasing service speed and delivery
Simplification of IT organization processes (e.g. Lean concept)
Building IT aimed 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
Business Intelligence solutions and data warehouses
Historical data migration

Development of software in the field of medicine

Formulation of IT processes, quality assurance of processed data
Software development in the medical industry
Implementation of methods such as KAIZEN, 5S, FMEA (Failure Mode and Effects Analysis), QFD (Quality Function Deployment), or SixSigma
Operation based on ISO 9001 standards and in the TQM (Total Quality Management) methodology

Software validation
Data integrity
Software quality management
Maintaining a validated state

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

Comprehensive quality management in matrix/integrated IT (TQM)
Just-in-time (JIT) services, increasing service speed and delivery
Simplification of IT organization processes (e.g. Lean concept)
Building IT aimed 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
Business Intelligence solutions and data warehouses
Historical data migration

Formulation of IT processes, quality assurance of processed data
Software development in the medical industry
Implementation of methods such as KAIZEN, 5S, FMEA (Failure Mode and Effects Analysis), QFD (Quality Function Deployment), or SixSigma
Operation based on ISO 9001 standards and in the TQM (Total Quality Management) methodology

How do we work

Meet our validation experts and learn about the challenges they face in their projects and responsibilities, and the solutions they provide to even the most complex problems.

Marcin: TTMS – Quality

Senior Lead and Team Validation

Validation of
systems in the AWS and SAP cloud

IT system validation is primarily Critical Thinking and Risk Based Approach. The key is to identify and assess the risks that the project needs to manage and minimize their impact on the "system intended use", patient safety and data integrity.

Andrzej: TTMS – Quality

Senior Validation-Qualification Manager

Qualification and GMP Validation

I deal with GMP audit, qualification of suppliers of active substances, immediate packaging and validation of computer systems. I validated equipment and processes. The scope of my experience and interests also includes audits of laboratories and contract manufacturers.

Mateusz: TTMS – Quality

Senior Validation-Qualification Manager

Validation Processes for Solid Forms of Medicinal Products

I have supervised the quality assurance and verified the validation and qualification processes for the area of manufacturing of solid-form medicinal products. I have participated in various activities, starting with planning and initiating validation and qualification processes, which are supported by a formal change control process, and ending with testing support and the approval of a complete set of documentation.

Piotr: TTMS – Quality

COO Quality

Digital Upgrade
Option Program

We have completed a project for the Digital Upgrade Option Program, the aim of which was to build and implement the process for the effective distribution management and implementation of digital product keys during a scaled motherboard production cycle of the leading global electronics manufacturers.