Transition Technologies Managed Services

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Take advantage of our "3D" 3Q service, which will allow you to offer top quality products

Prepare and verify CSV products with us

Entrust us with developing the approach, standards and procedures for both your current and subsequent infrastructure components

Expect documented results and verified operation of all systems according to the established parameters and quality requirements

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 take charge of planning, rationalization and reporting of the validation approach both in your projects as well as the 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., it aims to confirm that the devices, installations, systems or rooms have been designed and made to function in line with the architecture, user requirements, specifications, and 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 infrastructure consists in ensuring the highest operation quality of IT systems and the company or organization that uses 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 manner in which IT will manage new parameters, e.g., performance, software versions or security. The overall goal of the service is to establish 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 ?

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 medical data processing

Operational analytics and optimization
Data mining and data integration
Business Intelligence solutions and data warehouses
Historical data migration

Medical software development

Formulation of IT processes, data quality assurance
Healthcare software developmen
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, data quality assurance
Healthcare software developmen
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 Kraska**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 Zaborowski**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.

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.