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
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
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
The study reveals that $14.3 billion dollars worth of counterfeit drugs are sold yearly within Europe with Germany and Italy representing the majority of consumers
The survey asked around 14,000 people in 14 European countries Read more
The Food and Drug Administration (FDA) governs health and human services in the United States. It protects public health by enforcing safety and security regulations for drugs, vaccines, and other biological products and medical equipment. Read more
PRISYM ClinTrial is an ‘add-on’ software module to PRISYM Medica labeling software that provides additional features for managing randomized medical studies labeling and records for Clinical Trials. It is ideal for securely and accurately managing data for clinical trials supplies and complete patient kits / patient packs labeling that is completed in most clinical research trials.
PRISYM Inventory Manager for Healthcare is a feature rich, simple to use management tool which helps healthcare organizations keep track of the value of expensive medical inventory across multiple locations.
This tried and trusted software helps hospitals control fundamental inventory management requirements such as stock levels, locations, expiry dates, just-in-time reordering and stock history as well as live reporting on stock values.
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Any pharmaceutical or medical device manufacturer who does not use validated software, relies on costly manual and paper processes which may compromise the safety, quality and value of its products.
However, the software validation process can be extremely expensive and time consuming. Many companies employ full-time validation teams who are on a continuous global loop of validating and witnessing every computer system install and upgrade used in the production process – ‘the validation merry-go-round’. Read more
The MHRA (Medicines and Healthcare Products Regulatory Agency) was set up by the UK Government in April 2003 from a merger of the Medicines Control Agency and the Medical Devices Agency. The MHRA is the governmental agency responsible for standards of safety, quality and performance.
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