Validation – repeatedly performed and tested – and yet we are still finding ways to improve it. Ask us how we accomplish validation without paper – completely electronic.

Our validation service includes prospective and retrospective validation and certification of IT systems and equipment. Over the years, we have developed a highly efficient, risk-based ­validation approach based on the traditional ­validation approach with the classical phases of DQ, IQ, OQ and PQ. We have applied this very successfully in numerous projects in the entire life science industry. Systec & Services thus counts among the few providers who are experienced in both the entire GxP sector as well as the medical devices industry.

• Creating or improving company-wide validation standards and procedures
• Complete validation or qualification of computerized systems
• GMP, GLP and GCP compliance assessments
• Assessment of standards (ITIL, CMMI, and ASTM E2500)
• 21 CFR Part 11 compliance and planning
• Analysis and definition of compliant documentation
  such as Design History File (DHF), Device Master Record (DMR),
  Device History Record (DHR) and Electronic Batch Record (EBR)
• Retrospective computer system validation
• Network qualification and QM compliant IT management
• Audit support (suppliers, regulatory agencies and certification)
• Training planning and execution
• Test management: creation of test plans and test execution
• Requirement engineering and specification
• SOP creation (IT administration, operation and maintenance)