We provide a “three-dimensional” 3Q service that allows our clients to offer the highest quality products!


Validation - Quality management of computer systems

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. We do it both in projects and in the operational phase of automatic and IT systems.

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Qualification - Technical validation

During the qualification process, we provide evidence and demonstrate that the system operates in accordance with the established parameters and quality requirements.

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Safe IT processes - IT Infrastructure Qualification (ITQ) and IT Processes, Compliance and Security (ITCS)

Infrastructure qualification consist in ensuring the best performance of IT systems and the operation of the organization that uses these systems. During qualification, a general approach, standards and procedures for existing and new components are developed. In order to manage an effective IT organization, it is necessary to define IT processes well and to establish how 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 compliance regulations (FDA, GDPR, SOX) to ensure the legal and ethical integrity of the company.

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The sectors we support

Biotechnology
Biotechnology
Industrial automation
Industrial automation
Medicine
Medicine
Pharmacy
Pharmacy
IT
IT
Finances
Finances

Our services

VALIDATION OF COMPUTERIZED SYSTEMS
VALIDATION OF COMPUTERIZED SYSTEMS
  • Software validation
    We confirm that the software specification corresponds to the user’s requirements and the intended use. Software that requires validation is used to support regulated processes. It replaces manual actions.
  • Integrity data
    We provide database protection, thanks to which we can be sure that the data will not be modified, falsified or deleted. This is particularly important in the pharmaceutical industry when it comes to drug safety.
  • Serialization
    We protect against dispensing falsified medicinal products. Serialization provides security in the form of unique identifiers as well as devices that counteract data manipulation.
  • Software quality management
    We implement, test and maintain the computer system. We provide Software Quality Assurance, which focuses on the life cycle of a computer system.
  • Software validation in laboratories
    We take responsibility for validation activities in laboratories. We assess systemic risk, create validation reports, and help in the process of maintaining a validated system.
  • Software validation in laboratories
    We take responsibility for validation activities in laboratories. We assess systemic risk, create validation reports, and help in the process of maintaining a validated system


QUALIFICATION - TECHNICAL VALIDATION
QUALIFICATION - TECHNICAL VALIDATION

  • Qualification of installations and process utilities
    We make sure that water and compressed air installations, as well as equipment and support systems, can work stably and continuously. Their efficient operation affects the production equipment. Installation qualification applies to air conditioning, ventilation, purified water, injection water, compressed gas and steam installations.
  • Qualification of laboratory installations
    We make sure that water and compressed air installations, as well as equipment and support systems, can work stably and continuously. Their efficient operation affects the laboratory equipment and the results of laboratory analyzes. Installation qualification applies to air conditioning, ventilation, purified water, injection water, compressed gas and steam installations.
  • Qualification of production equipment
    We check whether the production equipment and support systems are operational. We qualify entire production lines, packaging and production equipment as well as auxiliary equipment.
  • Qualification of laboratory equipment
    We check whether the laboratory equipment and supporting systems are operational. We qualify incubators, sterilizers, laminar flow ventilation, stability chambers, HPLC.
  • Qualification of premises
    We check whether the premises are compliant with GMP requirements and HVAC recommendations before they are put into use. We perform environmental tests – we check humidity, temperature, airflow, etc. The premises qualification applies to production and laboratory rooms in zones A, B, C and D based on ISO14644-1, special rooms, storage rooms, and passenger and goods locks.
  • Validation of the production process
    Before a process is approved for serial production, it must be verified that it produces a good-quality product. As a result of the validation of the production process, we will receive documented evidence.
  • Validation of the washing process
    We check that the cleaning activity of the equipment thoroughly removes all pharmaceutical ingredients of manufactured products, cleaning agents and microorganisms. Thanks to this, we can be sure that the next manufactured product will not be contaminated by active waste from the previous product. Works are performed according to GMP rules. The validation of the washing process applies to rooms, washing production and auxiliary equipment, automated CIP processes and manual methods. The validation of the washing process also involves the development of a washing management strategy.
  • Validation of analytical methods
    We evaluate and document the characteristics of the analytical method, e.g. accuracy, repeatability, reproducibility, precision, linearity, stability, range, detection limit and quantitative limit. The result of this work is documented evidence that validation is appropriate for the purpose. The validation of analytical methods applies to chromatographic, spectroscopic and electrochemical methods.
  • Validation of medical devices
    The effect of validation of medical devices is documented evidence that medical devices are of high quality, and the production process is stable and there is no uncontrolled downtime.
  • Maintaining a validated state
    After the validation is completed, remember to maintain the validated state. This is the stage of transition to operation and maintenance. It involves managing incidents and changes, and making systematic reviews.


SECURE IT PROCESSES
SECURE IT PROCESSES

Modeling and quality management of IT processes

  • Comprehensive quality management in matrix and integrated IT (TQM)
  • Just-in-time delivery (JIT) services
  • Increasing the speed of service and delivery
  • Simplifying IT organization processes (e.g. Lean concept)
  • Building an IT oriented to internal and external clients
  • Operation cost management
  • IT management decentralization
  • Process redefinition (reengineering)
  • IT project/program management


QUALITY MANAGEMENT OF DATA PROCESSING IN MEDICINE
QUALITY MANAGEMENT OF DATA PROCESSING IN MEDICINE

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


SOFTWARE DEVELOPMENT IN MEDICAL INDUSTRY
SOFTWARE DEVELOPMENT IN MEDICAL INDUSTRY

We model IT processes and manage the quality of processed data in medicine. We also care about software development in medical industry. We perform all tasks based on ISO 9001 standards and according to the TQM (Total Quality Management) concept. We also implement methods such as:

  • KAIZEN
  • 5S
  • FMEA (Failure Mode and Effects Analysis)
  • QFD (Quality Function Deployment)
  • SixSigma
  • JIT (Just in time)
  • Kanban

We work based on

Cloud solutions
Cloud solutions

(SaaS Solution)

Databases
Databases
SAP Systems
SAP Systems
GMP process support tools
GMP process support tools
ERP Systems
ERP Systems
CRM
CRM
Process and Production Management Systems
Process and Production Management Systems
EAI Integrated Solutions
EAI Integrated Solutions

Portfolio

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The COVID-19 pandemic has meant that quality projects are carried out remotely. Our specialists have been working remotely for a long time, which is why we can very quickly offer you IT solutions that will help you remotely take care of quality in technological processes.

Contact us: quality@ttms.pl

We operate according to:

Worldwide quality standards
Worldwide quality standards

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  • ISO 9001
  • ISO 27001
  • ISO 27012
  • ISO 20000
  • ISO 45000
Worldwide process and design standards
Worldwide process and design standards

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  • PMBok
  • Prince2
  • Lean
  • ITIL
  • Agile
U.S. Food and Drug Administration
U.S. Food and Drug Administration

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  • 21 CFR Part 11 – Electronic Records, Electronic Signatures (Pharmacy i Medical Device)
  • 21 CFR Part 210 – Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs; General (Pharmacy)
  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (Pharmacy)
  • 21 CFR Part 820 – Quality System Regulations (Medical Device)
European Medicines Agency
European Medicines Agency

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  • ISO 13485 – Medical Devices
  • ISO14644-1 Cleanroom Standards
  • European Comission Council Directive 93/42/EEC
  • EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines
Polish regulations of the Ministry of Health
Polish regulations of the Ministry of Health

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Regulation of the Minister of Health of 9 November 2015 on the requirements of Good Manufacturing Practice
Industry standards
Industry standards

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  • Quality Management Systems – Process Validation Guidance (GHTF/IMDRF)
  • ICH Guideline: VALIDATION OF ANALYTICAL PROCEDURES: TEXT AND METHODOLOGY Q2 (R1)
  • ICH Guideline: GOOD MANUFACTURING PRACTICE GUIDE FORACTIVE PHARMACEUTICAL INGREDIENTSQ7
  • ICH Guideline: PHARMACEUTICAL QUALITY SYSTEMQ10
  • PIC/S GMP GUIDE
  • PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS)
  • PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE PHARMACEUTICAL INGREDIENTS)
  • PIC/S GMP GUIDE (ANNEXES)
  • ISPE Good Practice Guide: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
  • ISPE Good Practice Guide: A Risk-Based Approach to Electronic Records and Signatures
  • ISPE Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
  • ISPE Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition)
  • ISPE Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)
  • ISPE Good Practice Guide: IT Infrastructure Control and Compliance
  • ISPE Good Practice Guide: Global Information Systems Control and Compliance
  • ISPE Good Practice Guide: Good Engineering Practice
  • ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
  • ISPE Baseline Guide Volume 5: Commissioning and Qualification
  • ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC)
  • ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities (PACLAW)
  • ISPE Good Practice Guide: Process Gases
  • ISPE Baseline® Guide: Volume 4 – Water and Steam Systems (Second Edition)
  • ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems (Second Edition)

The greatest benefits from cooperation with TTMS Quality

Reliable technology partner
Reliable technology partner
Deep understanding of needs
Deep understanding of needs
Trustworthy Advisor
Trustworthy Advisor
Comprehensive Service Delivery (CSD)
Comprehensive Service Delivery (CSD)
Confidence in implementation, development and quality maintenance
Confidence in implementation, development and quality maintenance
Optimization and harmonization of process management
Optimization and harmonization of process management

About us

Our team consists of 30 quality engineers. It is a natural feature of each of us to care for quality in every aspect of our lives! Creativity is our middle name.

For many years we have been dealing with the validation of computerized systems and technical validation consisting in the qualification of devices, rooms and processes. Additionally, we model and manage the quality of IT processes.

We take care of continuous development by training at workshops and conferences. We also educate others by organizing our flagship project – Quality Academy. It is a series of meetings during which our mentors educate new employees, sharing best practices in the field of validation, qualification and IT processes.

How we work professionally results from the way we live our lives. Quality comes first!

About us

Our Competences

Contacts with industries on foreign markets
Contacts with industries on foreign markets

on all continents

Internal and external audits
Internal and external audits

nicotine and alcohol products industries

Contacts with respected institutions
Contacts with respected institutions

issuing production permits: The FDA, TUV Nord and TUV South, Main Pharmaceutical Inspector

Process maintenance and developme
Process maintenance and developme

validation, qualification and safe IT

Our certificates

Internal auditor of quality management system acc. to EN ISO 13485
Internal Auditor – Quality Management System ISO 9001
Internal auditor of FSSC 22000
Quality System Auditor in accordance with PN-EN ISO/IEC 17025:2005
Laboratory Quality Manager in accordance with PN-EN ISO/IEC 17025:2005
ITIL4 Foundation Certificate in IT Service Management Issuing
Prince2 Practitioner
Management of Risk (M_o_R) Foundation

About us

Contact

You can also send an email to: quality@ttms.pl!

PiotrZawadzki
Piotr Zawadzki

COO

Warsaw
+48 505 191 071

Or download our information booklet in PDF format.

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