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Take your business to TTMS Quality

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

In the picture:

TTMS Quality team

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
Piotr Zawadzki

COO Quality

Ask for an offer

TTMS Quality is a 4Q service that allows our customers to offer the highest quality products!

Q1

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.

Q2

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.

Q3

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.

Q4

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 KraskaSenior 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 ZaborowskiSenior 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.
Piotr ZawadzkiCOO 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.

Approved, certified quality In order to participate in projects from various sectors, we must regularly renew or obtain unique certificates due to our clients' requirements.

Concession to conduct business activity in the field of manufacturing and trading in products for military or police purpose

Environmental Management Systems

FSSC 22000

Guidance On Social Responsibility

Industrial Security Certificate - ESA EU / UE Secret & Confidential

Industrial Security Certificate - EU / UE Secret & Confidential

Information Security Management

Management Risk (M_o_R) Foundation

PRINCE2 Practitioner

Contact us!

We are at your disposal

Piotr Zawadzki

COO Quality

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