Transition Technologies Managed Services

You have an old version of the software. The website may not work properly. Please update your system to view the page with all available features.

Outsource IT processes to a trusted partner who will meet the highest standards
of qualification, validation, and security.

We provide a "4D" 4Q service that allows our customers to offer the highest 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 4Q service that allows our customers to offer the highest quality products!

Validation of computerized systems

Validation is a comprehensive consulting and strategic supervision service in respect to the design quality activities for CSV / CSA (GAMP 5.0). You can exoect us to prepare, consult and analyze implementation models for quality processes in IT. We are also responsible for planning, reviewing, and reporting the quality approach in various projects and the operational phase for IT systems, automated based on #aaS solutions.

Qualification of equipment and processes

During the qualification process, we provide documented evidence and demonstrate that the system operates following the established parameters and quality requirements. The aim is to validate the devices, installations, systems or rooms as designed and made in accordance with the project specification, URS and any applicable standards. We also scrutinize and make sure that these items are suitable for the implementation of planned processes. This applies to production and laboratory devices as well as the IT hardware infrastructure. Qualification is a component of validation, and its first stage.

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.

Audits

Audits of ISO standards and active substance manufacturing processes (ISO 27001, ISO 14001, ISO 50001, ISO 9001, ISO 45000, ISO 13785, GAMP 5.0, GMP) are the main areas of competence of the auditors accredited in TTMS Quality. Using the many years of experience gathered in team, we implement, prepare for accreditation audits and maintain the compliance of processes with the standards implemented in the organization.

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.

TTMS-Q model validation process

**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.