Validation review

Validation service

According Annex 15 of the EU GMP directive, facilities, systems, equipment and processes, including cleaning, should be periodically evaluated to confirm that they remain valid.

Processes and regulations may differ in the various sectors of the life science industry, but one constant remains: the environment must be safe, secure, efficient, and compliant. We provide a solution portfolio ranging from HVAC controls to fire safety and security technologies that help you establish an optimal environment as well as ensure efficient production processes and reliable validation.

Moreover, our systems are flexible and scalable. Should your production, and thus the required room conditions change, all systems can be quickly and easily adapted to the new environment to meet the new regulations.

21 CFR Part 11 audit

The security of systems and data is a high priority driven by regulation, e.g. 21 CFR Part 11 and EU GMP directive Annex 11.

During the assessment we analyze in detail the

  • system access ­

  • data security ­

  • audit trail ­

  • related documents and ­

  • record retention of the related building management systems.

Also system documentation, device checks and education status is part of the audit. In addition for each gap we find, a recommendation is given.

Calibration

All EU GMP or FDA cGMP regulated facilities are required to routinely calibrate all critical process equipment. This includes, but is not limited to HVAC controls, laboratory instrumentation, environmental monitoring and process equipment. Siemens specialists verify, calibrate and document the qualified portions of the building automation and control system. Our calibration services ensure that critical measurements are within the required tolerances.

Your benefits

  • ­An independent and documented evidence of your system ­

  • Reduce risk of the facility‘s system operating out-of-tolerance ­

  • Ensure system integrity during the calibration process ­

  • Maintain calibration certificates and sensor history log with deviations

  • Provide repair services for sensors as necessary


Advantage services

With our Advantage Services program we provide a comprehensive service portfolio for any life science building. Profit from the largest service network in Europe, with the speed of a local partner and the power of a global corporation.

Our advantage services program comprises of the following services:

  • Life cycle management

  • Energy optimization services

  • Alarm management

  • Operational services

  • System maintenance

  • Knowledge services

A long-term partnership with Siemens enables you to have a single point of contact, from planning and implementation through to system maintenance. Siemens’ global service network and extensive knowledge in various markets, combined with local expertise, gives you access to the right information and services – anytime, anywhere.