SMART quality & compliance
Data Integrity: Risks and Solutions
To ensure patient health and product quality, adhering strictly to Good Manufacturing Practice (GMP) is essential. One part of GMP, which is increasing in importance within the last few years due to higher FDA focus, is Data Integrity. Data Integrity means the overall documentation of every GxP-relevant activity performed during the whole product life cycle. The FDA recommends that this documentation should be based on the ALCOA principles. To guarantee Attributable, Legible, Contemporaneous, Original and Accurate documentation, life-science companies increasingly seek experts for advice. Focusing on data integrity by kicking off respective projects and hiring consulting experts within this field…
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SMART quality & compliance
Eight Critical Success Factors to be considered in Times of Organizational Change and Transformation in Regulated Environment (Practical View)
“The Only Thing That Is Constant Is Change” (Heraclitus) In today’s globalized and fast changing world, it is very common that life science companies around the globe not only buy and sell entire subsidiaries, but also single parts of their operations and business units. In the highly regulated life science environment, such transactions should be compliant with local and global GxP regulations and in line with IT governance industry standards. For the information technology departments in the regulated life science space, this becomes more and more complex and of growing significance. One of the reasons for this is that IT…
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SMART quality & compliance
Stricter… Harsher… Narrower…? GMP guide improvement of best practices in the area of Quality
The pharmaceutical industry is a highly regulated and controlled sector of economy. Development, manufacturing, and management of medical products are carefully examined and analyzed in order to ensure amenability with present requirements of safety, quality and efficacy. European Union authorities ensure that all medical products on the European market are manufactured or imported by authorized producers or approved partners. All activities regarding manufacturing, repacking, transporting, and so on are described in the GMP guidelines. It ensures that goods are consistently made and controlled according to updated standards. In addition it minimizes the risks tangled in any medicinal production that cannot…
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SMART quality & compliance
Digital Health Compliance
“I think the biggest innovation of the 21st century will be at the intersection of biology and technology. A new era is beginning” Steve Jobs On the Brink of Innovation You might not know it yet,but you are living in the digital era. You may have heard a friend talk about it, heard something on the news, or even downloaded an app. Whatever it is, digital healthcare is becoming the IT thing. More and more digital health applications are installed on smartphones, a number that is foreseen to grow exponentially. The United States alone is investing some 1.6 billion dollars…
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