The FDA’s mandate for Unique Device Identification (UDI) of medical devices aims to offer a practical solution which proposes a standard way of presenting standard information in a standard format or barcode. Read more
7 Jun
2010
Though the principles of serialization are fairly straight forward, there’s more to serialization than just generating numbers. Especially in the tightly regulated and compliance-led world of pharmaceutical manufacturing and packaging. Read more
7 May
2010
The National Patient Safety Agency (NPSA) leads and contributes to improved, safe patient care by informing, supporting and influencing the health sector. It represents a body of the Department of Health which aims to reduce risks to patient safety in UK health service by overseeing techniques and guidelines that help in proper patient identification. Read more
6 May
2010
Counterfeit drug revenues are estimated to be in the region of $75 Billion in 2010 and are projected to grow at 13% annually. The World Health Organisation states that it is impossible to quantify the size of the problem but that it may be as much as 10% of the global market. Read more
The supply of counterfeit medicines and medical devices is a growing problem worldwide. The World Health Organization (WHO) estimates that up to 1% of medicines available in the developed world are likely to be counterfeit. This figure rises to 10% globally, although in some developing countries they estimate one third of medicines are counterfeit. Read more
25 Mar
2010
The fourth Oracle Life Sciences Forum, held in Geneva on the 16-17th March covered a broad range of subjects including clinical development & safety, manufacturing, distribution & operations, customer relationship management and collaboration & architecture. Read more
22 Mar
2010
PRISYM Medica is a purpose designed labeling software solution for Life Science organizations specifically developed to meet the FDA’s current 21 CFR Part 11 compliance requirements. PRISYM Medica is supplied as a validated labeling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model. Read more
18 Mar
2010
The UK’s NHS is under continuous pressure to allocate over two million prescription items per working day. Mistakes can easily be made and recent figures from the General Medical Council have shown that one in ten hospital prescriptions contain errors that could harm patients. Read more
14 Mar
2010
Good Manufacturing Practice, GMP compliance, is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMP standards are concerned with both production and quality control. Read more
