QualUs is a commissioning and validation contract service company servicing the bio-pharmaceutical, medical device, hospital/dental and related life science and healthcare industries. It’s main office is located in the Acorn Business Centre, Mahon Industrial Park, Blackrock, Cork. Ireland T12K7CV. QualUs offer a range of services including:
QualUs only provide personel with previous experience in the area that you require so they can hit the ground running with minimum project time wastage for you the customer. QualUs have successfully executed and delivered large scale validation exercises for multinationals in Ireland and the UK such as Schering-Plough, Janssen, Centocor, Eli-Lilly, Vistakon, Cordis, Taro, Patheon, Elanco, GE Healthcare, MSD and Boston Scientific. All QualUs equipment is calibrated by an accredited laboratory that is traceable to national standards. The following are some of the additional benefits:
QualUs utilise the latest 21 CFR 11 compliant data logging hardware and software from GE Sensing, Hanwell and Fluke which means that study setup, study execution and report generation time has been reduced. This leads to a greater choice and more cost effective solution for you the client.
All of our loggers allow logged data to be viewed in real time. This minimises equipment downtime as problems can be identified at an early stage. All QualUs equipment is calibrated to national standards and can be calibrated pre-study execution and verified post-study execution.
I can assure you that you will not be disappointed with the quality of our documentation as Good Documentation Practices (GDP) is one of the key areas that we excel in. Our engineers recognise the importance of GDP and are fully trained on all applicable regulations (such as EN285, HTM2010, HTM01) to ensure customers are compliant from a thermal validation perspective.
Our validation engineers are capable of defining your validation requirements from a regulatory perspective and from this they can prepare concise protocols in either a QualUs format or in a client specific format
If you would like a quote or if you have any questions then please contact us by e-mail at email@example.com or by phone on 0868790922.