Take advantage of our "3D" 3Q service, which will allow you to offer top 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 "3D" 3Q service
Q1
Validations
Validation is a service of consulting and strategic supervision over CSV activities. We prepare and verify CSV products and take charge of planning, rationalization and reporting of the validation approach both in your projects as well as the operational phase of automated/IT systems.
Q2
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., it aims to confirm that the devices, installations, systems or rooms have been designed and made to function in line with the architecture, user requirements, specifications, and correct standards, and that they are suitable for implementation of the planned processes. This applies to both production equipment and IT infrastructure. Qualification is the first stage of validation.
Q3
Safe IT processes
The qualification of infrastructure consists in ensuring the highest operation quality of IT systems and the company or organization that uses 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 manner in which IT will manage new parameters, e.g., performance, software versions or security. The overall goal of the service is to establish 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.
Q1
Validations
Validation is a service of consulting and strategic supervision over CSV activities. We prepare and verify CSV products and take charge of planning, rationalization and reporting of the validation approach both in your projects as well as the operational phase of automated/IT systems.
Q2
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., it aims to confirm that the devices, installations, systems or rooms have been designed and made to function in line with the architecture, user requirements, specifications, and correct standards, and that they are suitable for implementation of the planned processes. This applies to both production equipment and IT infrastructure. Qualification is the first stage of validation.
Q3
Safe IT processes
The qualification of infrastructure consists in ensuring the highest operation quality of IT systems and the company or organization that uses 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 manner in which IT will manage new parameters, e.g., performance, software versions or security. The overall goal of the service is to establish 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.
PMBok
Prince2
Lean
ITIL
Agile
Cloud solutions
SaaS Solution
Data bases
SAP Systems
GMP process support tools
ERP Systems
Process and Production Management Systems
Enterprise Application Integration solutions
ISO 9001
ISO 27001
ISO 27012
ISO 20000
ISO 45000
ISO 13485
Medical Devices
ISO14644-1 Cleanroom Standards
European Comission Council Directive 93/42/EEC
EudraLex
Volume 4 Good manufacturing practice (GMP) Guidelines
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)
Regulation of the Minister of Health of 9 November 2015 on the requirements of Good Manufacturing Practice
Medical software development
Quality management in medical data processing
Safe IT processer
Qualification - technical validation
Validation of computerized systems
Meet our validation experts and learn about the challenges they face in their projects, as well as the responsibilities and solutions they provide in 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 have supervised the quality assurance and verified the validation and qualification processes for the area of manufacturing of solid-form medicinal products. I have participated in various activities, starting with planning and initiating validation and qualification processes, which are supported by a formal change control process, and ending with testing support and the 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 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.
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