Raise the quality and develop it with TTMS Quality

We will take care of the highest quality of your services confirmed by quality standards

In the picture:

TTMS Lublin Team

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 planning, rationalization and reporting of the validation approach both in projects and in the operational phase of automatic and 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 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.

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.

Validations

Qualifications

Safe IT processes

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

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

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.

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 supervised in terms of quality and verified the validation and qualification processes for the area of manufacturing solid forms of medicinal products. I attended in various activities, starting with planning and initiating validation and qualification processes, which are supported by a formal change control process, and ending with participation in tests and 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 an effective distribution management process and the implementation of digital product keys during the scaled motherboard production cycle of global mass electronics manufacturers.