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

Staying compliant and flexible

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 through to safety 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