EmpowermentQE is a specialist Quality Assurance and Control organisation, helping software and IT across the Pharmaceutical and Life Sciences,
Telecommunication, Financial services and Automotive communities.
Our sensible and pragmatic approach focuses on adding value. We help you improve the quality and performance of your computerized systems, enhance your project deliverables, enable you to achieve faster time to market for your products and reduce your project and operational costs.
As your chosen partner you don't need to worry about placing strain on your resources, together we can solely focus on achieving the end result.
We see things differently due to our background in software engineering. We understand the complexity of software and the real cost of quality. Leverage our vast industrial knowledge in:
- Quality Assurance
- Quality Control
- Business Analysis
- Computerized Systems Verification & Validation
- Process Improvement
- Tool Selection
- Bespoke Training
- Managed Test Services
RQA Irish Regional Forum
The Irish Regional Forum is taking place on the 19th March 2015 at ICON, South County Business Park, Leopardstown, Co. Dublin, Ireland. 10:00-15:45, Registration 10:00am.
The Forum's theme is titled 'GxP Allsorts' and is touching on some interesting areas.
- The Impact of Clinical Trials Regulation - from the non commercial perspective (Stephen Liggett, Research Governance Manager QUB) to the Sponsor perspective (Mark Rutter Associate Director of Regulatory affairs, Abbvie via Webex).
- GLP update - Marie O’Mahony Quality manager at INAB.
- Medical Devices updates - Colette McIntyre, GLP/GCP Specialist at Heartsine / Chair RQA Medical Devices Committee.
- GMP update - Ann McGee McGee Pharma International.
The Ireland Regional Forum is FREE for all RQA members and those people interested in RQA membership.
We're audit partners for Bayer Health Care
We are assisting Bayer Health Care audit their Computerised System Suppliers
Bayer Health Care is among the world's foremost innovators in the field of pharmaceutical and medical products. Their mission is to research, develop, manufacture and market innovative products that improve the health of people and animals throughout the world.
Bayer Health Care has four operating divisions: Animal Health, Consumer Care, Medical Care and Pharmaceuticals. With over 55,000 employee, the group is dependent on compliant computerised systems (CS) within a GxP environment.
EmpowermentQE are proud to be in a position to apply our CS technical and auditing expertise to help meet Bayer Health Care's objectives. With two GCP IT supplier audit under our belts, we are looking forward to continue to provide our knowledge and perception in the future.
Click here for more information on Bayer Health Care
We're QA partners for Codec-Dss
We are QA partners for Codec-Dss
have been providing end 2 end IT solutions for medium and large scale enterprises in the European market place since 1985: from hardware implementation and consolidation through to Enterprise Performance Management and Business Intelligence.
Codec-Dss are passionate about meeting their client's objectives in a quality focused, timely and cost effective manner. This is an ethos that is shared by EmpowermentQE and we are delighted to be the QA partner for Codec-Dss and augment their highly skilled team in delivering value add for their clients.
Click here for more information on Codec-Dss
Recent CSV seminar in Cork.
A Software Engineer's Perspective on the Challenges of CSV
Thanks to all of the delegates from Novartis, Janssen and Bayer Health Care who attended our recent seminar in Cork. Especially, the Bayer delegates who travelled from New Jersey and Switzerland.
The objective of the seminar was to discuss the perspective of software engineering towards CSV and the challenges facing the delegates based on the topics they each requested prior to the event. Barry started with a look at some common verification and validation definitions and how they may be applied 'slightly' differently within the wider software engineering community. The majority of the first session examined the complexity of producing computerised systems and some of the techniques that may be applied to ensure on time delivery, right first time acceptance (validation) and reduce costs and how to devise a risk based test approach.
The second session looked at "Leveraging 3rd Party Suppliers" (Least Burdensome Approach). This theme was carried forward into a discussion on how to "Validate the Cloud", with a brief look at what to consider during an "Audit of a Cloud Supplier".
This was a diverse group of delegates who expressed an interest in a wide range of topics, (which may have been heavy going to recent converts from a non CSV/Auditing background). The complexity of software and risk based test discussion was the most popular for the group. We were happy to find that all delegates responded that they had some new ideas to take back to their working environments. With the positive feedback, Ciara is already plotting the next seminar!
If you are interested in any of the content topics or want to find out more about our bespoke training service, please contact us via our Contact Us page.
What the delegates said:
"Well presented & friendly staff", Janssen "Generated some ideas for me to take into our CSV approach", Janssen "Interesting Topics", Bayer