ONE VALIDATION TEAM, MANY VALIDATION EXPERTS.
Validation services for medical devices
Minimizing business risks, stable manufacturing processes, and product safety are just a few good reasons why Validation Services by Systec & Services GmbH are important for the medical devices industry.
As experts with many years of experience in computer system validation (CSV), we support you in complying with regulatory standards on a national and international level – and help you to master regulatory challenges with user-oriented and efficient processes.
- Risk management with risk-based validation approach
- Analysis of the QM system (QMS) with regard to the validation processes
- Creation of a validation plan as a definition of the project and validation strategy
- Performance of computer system validation (CSV), including equipment and system qualification
- GAMP®5 based solutions and use of the V-model or alternative procedures (further customer-specific compliance solutions possible)
- Creation of standard operating procedures (SOPs) and training management
- Consulting on data integrity
- Complete audit management and support
- Computer system validation of spreadsheets and cloud computing (IaaS, PaaS, SaaS)
Experts in the medical devices industry
Since our validation experts are familiar with the medical devices industry, we offer you tailor-made expert knowledge:
- Evaluation and optimization of the QM system and technical documentation according to Medical Device Regulation (MDR) and EU regulation 2017/745 on medical devices
- Compliance Management Services under consideration of ISO 13485, FDA 21 CFR Part 820 and Part 11 - Electronic Records / Electronic Signatures (ERES)
- Audit management and support, e.g. as preparation for an MDSAP - Medical Device Single Audit Program
- Specialists in medical devices validation, with international customers
- Scalable for the needs of all sizes of companies
- Customer-specific validation of computer systems
- Compliance with the regulatory requirements of national and international guidelines
Validation consulting for medical devices
You want more? We are happy to offer you consulting services in the field of validation that go beyond our validation services. The focus is on strategic and organizational aspects to improve your business areas.
- Optimization of your processes
- Analysis and evaluation of business and process risks
- Development of a appropriate quality management system (QMS)
- Definition of project and validation strategy
- Seminar management and implementation