We understand about compliance and engineering audit trails - it’s embedded in everything we do.

If you are transferring equipment into Europe or placing it on the market within the EEA/EU then CE has to be fully considered along with any additional client process safety and occupational safety directives.

We can assist developing an initial basis of safety risk assessment and even support in Hazardous Area Classification under IEC61241-10 and IEC 0079-10 through to component selection within 94/9/EC ATEX 100a including ignition risk assessment EN1127-1. This usually requires a review of protective systems, especially those that were not previously subject to a formal certification process. Where necessary or when the area classification dictates we work with a number of Notified Authorities for associated certification. Naturally American ASMI/29CFR1910 standards would apply depending on the final location...

Our years of experience of projects within both blue chip multinational and generic manufacturers alike has provided us with a thorough understanding of cGMP enabling us to offer a pragmatic and comprehensive solution.

Lastly with our control systems if required these are offered to ISPE baseline guides and GAMP5 along with 21CFR pt 11 as applies.