Environmental Concept

Complex life science processes require a complex building infrastructure tailored to the exact on-site needs of the customer. Detailes knowledge on infrastructure, functionality and production processes are mission-critical to avoid “validation overkill”.

Complete tailored solution based on:

• Customer specific business processes

• Impact and risk assessment

• Regulation and industry standards

• Financial resources

Increase your Immunity to Risk

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.

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 not only helps us assess your current requirements, but 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 requirement changes or misinterpretations; raise awareness for possible challenges within the infrastrcure for each modification

• Accelerate project execution reduce validation efforts

• Identify the critical compnents within your environment to keep the proper focus

• Reduce validation expenses

• Clear and justified definition of your validation strategy