The Cold Chain unit was qualified on site by FQS. They performed the Installation
Qualification (IQ), Operational Qualification (OQ) and the Performance Qualification (PQ).
The work was completed ahead of schedule with a very high standard. The report was well
presented and meeting all in-house and required regulatory requirements. Their
understanding of Data integrity was excellent with all ALCOA principles clear within all their
work, and CFR21 Part 11 compliant software was used. This qualification ensures our
business is complaint and ensures it meets our regulatory requirements and the equipment
runs efficiently and effectively.
Hugh McGovern, Warehouse Manager
approachable and professional. If an issue ever arose, Irene investigated exhaustively and promptly suggested corrective and preventative measures which were always compliant, cost effective and achievable within specified timelines.
Her knowledge of legislation and requirements is excellent and her problem solving ability is highly innovative. I wish Irene and FQS every success in the future.
Marie O'Callaghan, QA Manager
Sanofi Aventis Waterford
I’m very happy with FQS and the quality of their work, and our finance department is also satisfied because costs are being kept to a minimum’.
Large Multinational Pharmaceutical Company
Protocols and reports contained up to date relevant information meeting all the requirements of different regulatory authorities and were written in an easy read format. I found that reports were returned in a timely fashion and a logical reason was always provided for each logging position following the risk assessment of a location.
‘I would not hesitate in calling FQS with a compliance or temperature mapping query. FQS are reliable and always follow up punctually – I would recommend them without reservation’.”
Kevin O'Hara, Warehouse Manager
With FQS you can expect an exceptional service and a high level of expert guidance which is delivered in a professional, efficient and personable manner’.
Sean Dunne, Managing Director
Irene is happy not to only get involved in all aspects of the day to day management of QMS and associated processes and procedures but also to support brainstorming and other group activities and as such, she is well respected and looked upon as an integral part of the team.
She makes herself available and contactable at all times and always flexible to meet to discuss and work on issues whether early in the day or late in the evening. This has proven to be a great asset when trying to achieve tight timelines and implement urgent processes.
Irene’s vast knowledge and experience means that any company working with here can be assured that she will strive to maintain regulatory compliance and I therefore have no hesitation in recommending Irene and her services.