Developing and maintaining a quality management system for IVDs

| October 12, 2018

article image
There are many different requirements with which in vitro diagnostic manufacturers must comply in order to place the product on the market. At the core of most of these requirements is a fundamental need to have a good quality management system (QMS) in place. This is certainly not a new requirement for companies. Philip B. Crosby said  ‘Quality Management is a systematic way of guaranteeing that organized activities happen the way that they are planned Quality management is needed because nothing is simple anymore if indeed it ever was’. Although this quote is now nearly 40 years old, it is as true today as it was then.

Spotlight

Sobi - Swedish Orphan Biovitrum AB (publ)

Sobi is an international specialty healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients.

OTHER ARTICLES

The Future of Pharma Beyond Blockbusters

Article | March 17, 2020

We’ve all heard the saying “treat the patient, not the disease”, and this couldn’t be truer in today’s ever-changing pharmaceutical landscape. We are living in a time of revolution – advancements in genomics and technology are improving our ability to develop precise drugs and targeted therapies, rather than focusing on a one size fits all approach. Each individual’s genetic makeup is slightly different from everyone else’s,

Read More

Top Specialty Pharmacy Therapy Areas

Article | March 16, 2020

Accelerated by advancements in cancer treatments and a growing emphasis on personalized and precision medicine, specialty pharmacy represents a rapidly growing sector within the healthcare industry. In fact, the market is projected to grow to $500 billion by the end of this year—up from $200 billion in total U.S. specialty drug spending in 2017. Industry growth of this magnitude creates challenges for those looking to understand and penetrate the market. It can be difficult, after all, to maintain updated information about high-priority drug therapy areas or facility affiliations in a market that’s constantly changing.

Read More

What do you have to lose taking hydroxychloroquine for coronavirus? Potentially your life

Article | April 10, 2020

The president and some of his close advisors — desperate for a COVID-19 cure — are asking “What do you have to lose?” by taking hydroxychloroquine (HCQ), a strong medication never adequately tested for efficacy or safety in COVID-19 patients. The correct answer to the president’s question, which he doesn’t seem to want to hear, is that we have our lives to lose. The president acknowledges “I’m not a doctor” but this raises the question “What do doctors know about the drug recommended by the president? Most doctors are aware that HCQ can be effective for patients with malaria, arthritis or lupus. If they were to follow the president’s suggestion and prescribe it for COVID-19 patients, they would also like to know that it will benefit some of those patients, at least.

Read More

Advance Your Pharma Supply Chain Planning during a Pandemic

Article | March 20, 2020

One predominant and common element within our pharmaceutical industry, is our devotions to patients. Within supply chain there is always a focus on ensuring the right product is delivered to the right place at the right time in order to ensure patient safety and the continuity of medicinal supplies. With the spread of COVID-19 across 117 countries and counting, every supply chain needs to evaluate their global footprint and develop contingency plans within their end to end operations.

Read More

Spotlight

Sobi - Swedish Orphan Biovitrum AB (publ)

Sobi is an international specialty healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients.

Events