TTMS Quality is a 4Q service that allows our customers to offer the highest quality products!
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.
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.
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.
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.
GMP process support tools
Process and Production Management Systems
Integrated EAI Solutions
ISO14644-1 Cleanroom Standards
European Comission Council Directive 93/42/EEC
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
21 CFR Part 820
Quality System Regulations (Medical Device)
Ordinance of the Minister of Health of 9 November 2015 on the requirements of Good Manufacturing Practice
Validation of computerized systems
Qualification - technical validation
Safe IT processes
Quality management in medical data processing
Medical software development
COO-Quality / CSV Team Lead