We will maximize your success – take us at our word.

• Optimal teams are put together for optimal success in the validation and IT project
• IT expertise available within the company (e.g. ISO 12207, ASTM E2500, CMMI)
• Compliant software development methods with waterfall model, Rapid Application Development (RAD) or Rational Unified Process (RUP)
• Extensive, detailed documentation templates for the entire validation and project lifecycle with proven and “read-to-use” packages
• Combined project and validation management through utilization of pre-configured tools
• Standardized methods for minimizing risk and increasing efficiency (ICH Q9)
• Extensive, up-to-date library of regulations, guidelines, directives and standards (e.g. GAMP®5 and numerous Good Practice Guides)
• Basic design and tools for validation (VMS – Validation Management System)
• Our own ISO certified Quality Management System

Our comprehensive Quality Management (QM) Service includes consulting and proactively ­designing your QM processes since these are increasingly merging with the IT landscape into a holistic approach.

Our focus is on integrating various QM elements in the most practical, efficient, and pragmatic manner.

• Design and creation of a QM system: Quality management manual, procedural instructions and work instructions
• Design of the QM and production processes for the Quality by Design (QbD) approach
• Corrective Actions and Preventative Actions (CAPA), deviation management, change control
• Training seminar management and learning supervision

The goals and content of audits are becoming increasingly numerous and specialized. In par­ticular, the FDA audit is not necessarily difficult in terms of the specific content but which still differs from the European method in terms of the American terminology, way of thinking and definitions. Systec & Services has highly specialized itself in exactly this area, benefiting from a trove of experience from numerous, successful FDA audits.

Our projects aim to guarantee that our ­customers be “inspection ready” at any time.