ONE VALIDATION TEAM, MANY VALIDATION EXPERTS.
Validiation services for the pharmaceutical industry and biotechnology
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 pharmaceutical and biotech companies.
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 pharmaceutical industry
Since our validation experts are familiar with the pharmaceutical industry, we offer you tailor-made expert knowledge:
- Compliance Management Services under consideration of ISO 9001, EU GMP Annex 11, FDA 21 CFR Part 210/211 and Part 11 - Electronic Records / Electronic Signatures (ERES)
- Computer system validation of Manufacturing Execution Systems (MES) and MES consulting including recipe consulting (e.g. for Werum PAS-X or Rockwell Automation PharmaSuite)
- Business process management and audit management, e.g. as preparation for an FDA audit.
- Specialists in pharma validation, with customers ranging from small and medium-sized companies to global top 10 pharmaceutical companies
- 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 ServicesPharmaceutical Industry and Biotechnology
Validation consulting for pharma and biotech
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