by Ryan Watts | Jan 27, 2015 | Quality Systems
Instead of monitoring the signs around us of quality failure, such as the worrying observation that since the early 1990’s the number of product recalls reported by consumer product safety commissioners around the world has increased by almost 5 times, let us turn...
by Kimberley Peck | Dec 19, 2014 | Business, Quality Systems
DATA INTEGRITY – is Mickey Mouse filling in your documents? What is data integrity? The extent to which all data are complete, consistent and accurate throughout the data lifecycle. From its generation and recording to use, retention, archiving, retrieval and...
by Jackie (née Heneghan) Peck | Nov 17, 2014 | Blog, Quality Systems, Transportation, WDA(H), WDA(H)
We often hear people stating that they don’t actually handle medicinal products, therefore they do not need a WDA – this is not strictly a correct statement. Even if you do not, physically, handle medicines, you will need to either register as a broker...
by Jackie (née Heneghan) Peck | Nov 10, 2014 | Blog, MHRA, Quality Systems, Regulation, Training, WDA(H), WDA(H)
The MHRA has today, 10th November 2014, published their guidance on their expectations for the supply of medicines to the maritime sector. http://www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON473634 Any UK marine company procuring, storing,...
by Jackie (née Heneghan) Peck | Aug 13, 2014 | Blog, Good Distribution Practice - GDP, Quality Systems
During the course of our work we often find that there is little understanding of what a quality manual is and what should be in it. Simply, the quality manual forms the basis for your quality system and is the ‘what you do’, whereas the SOPs are the...
