





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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(SaaS Solution)
IT system validation is primarily Critical Thinking and Risk Based Approach. The key is to identify and assess project risks and minimize their impact on the “system intended use”, patient safety and data integrity.
In order to provide the client with a solution that meets his expectations, we must flexibly plan the validation, required products and supporting tools. An experienced Project Manager and Validation Specialist will be indispensable. These are the foundations of effective system support in the operational phase.
The IT system is also its specifications, risk matrix, tests and reports that must be prepared in a smart manner, so that they are undisputed proof of validation for the auditor and, at the same time, material for the work of the project team.
Therefore, in our everyday projects, Computerized System Validation is increasingly evolving towards Computerized System Assurance, and Documentation Management towards Records Management.
I deal with GMP audit, qualification of suppliers of active substances, immediate packaging and validation of computer systems. I have validated equipment and processes in the past. The scope of my experience and interests also includes audits of laboratories and contract manufacturers.
I carried out full GMP audits from the quality side and audits of ISO requirements. My activities mainly concern the pharmaceutical industry, as well as food and cosmetic companies. I was hired to pinpoint optimal solutions prior to inspections. I was getting great feedback then!
I also deal with the rescaling of biotechnological processes.
I supervised the quality and verified the validation and qualification processes during the production of solid forms of medicinal products. I participated in various activities, starting with planning and initiating validation and qualification processes that are subject to a formal change control process, and ending with participation in tests and approval of a complete set of documentation.
With a 30-person management team and subcontractors, we completed the scope of tasks for the Digital Upgrade Option Program. Our goal was to build and implement an effective management process for the distribution and implementation of digital product keys during the scaled motherboard production cycle of global electronics manufacturers. The scope of tasks included, among others:
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
Our team consists of 50 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!
on all continents
nicotine and alcohol products industries
issuing production permits: The FDA, TUV Nord and TUV South, Main Pharmaceutical Inspector
validation, qualification and safe IT
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
Internal Auditor ISO 14001:2015
Internal Auditor EN ISO/IEC 27001:2017
Lead Auditor EN ISO/IEC 27001:2017
ITIL4 Foundation Certificate in IT Service Management Issuing
Prince2 Practitioner
Management of Risk (M_o_R) Foundation