Compliance consultancy

Compliance consultancy

Environmental Concept

Specific life sciences processes require a multifaceted building infrastructure tailored to the exact on-site needs of the customer.
Your success is based on the exact combination of organizational measures, proper environmental structure, and the ability to fit your current and future needs. Together we investigate site specific business processes and draft a solution concept tailored to your precise needs.

Complete tailored solution based on:

  • ­Customer specific business processes ­

  • Impact and risk assessment ­

  • Regulation and industry standards

  • Financial resources

The right combination guarantees sustainable success

  • Whether planning a new site or expanding an existing facility - we work with you to maximize your options taking advantage of our knowledge.

  • The result is an environment concept that covers the regulatory aspects, industrial and company standards, as well as available resources.

  • Working with your specialists, we examine the possible impacts of the building structure on product quality and assess GxP, business and security risks.

  • Your individual solution is composed of technical systems developed for the life sciences industry and operational measures required integrating your building and IT structures.

Providing dedicated operation and maintenance systems

  • The conceptual groundwork established during the planning stage both helps us assess your current requirements and further allows us to plan for the future of your facility.

  • Changes, expansions and migrations and their potential impact are structured into the solution with future goals in mind.

  • During design, engineering and installation stages you can be sure that our execution procedures meet the needs of the industry and efficiently support validation activities.

  • System integrity tests, calibration, base lining and SOP maintenance as well as training for your operational staff.

Your benefits

  • Significantly reduce the risk of required changes or misinterpretations ­

  • Raise awareness for possible challenges within the infrastructure for each modification

  • Accelerate project execution ­

  • Reduce validation efforts and costs ­

  • Identify the critical components within your environment

  • Clear and justified definition of your validation strategy