FDA

Adverse drug reactions (ADRs) refer to unwanted or harmful reactions experienced following the administration of a medication. In Canada alone, the Adverse Drug Reaction Institute has estimated that there are approximately 200,000 severe ADRs each year, though it is believed that 95% of ADRs are not reported to drug manufactures..... Read More

Pharmaceutical companies have a duty to the FDA and other authorities to keep their data accurate, unaltered, and properly stored in their database. Not only should the data be stored, but it should also be maintained through error checking and validation routines. Failure to do so will result in a..... Read More

The beginning of a new year usually implies a fresh, optimistic start, but it would appear that things are still not looking good for pharmaceutical companies in 2017. The life sciences sector has seen some rough times in 2016 already—Donald Trump’s criticisms of the pharmaceutical industry alone raised more than..... Read More

Computer System Validation has been a regulatory (e.g. FDA, Health Canada) requirement for more than two decades. Nevertheless, companies have problems with its understanding, scope, implementation and maintenance. This is proven through many FDA warning letters related to device software and computer system validation. IT professionals know the principles but..... Read More

The pharmaceutical and life science industry is among one of the most heavily regulated and scrutinized in the world. These businesses are constantly adapting to numerous regulatory requirements set by governing bodies around the globe like Health Canada and the FDA. Business practices for these life science companies must be..... Read More

Life science companies are facing challenges in response to an increasingly complex regulatory environment. These businesses have to address various requirements that span across geographies, business activities, and processes. Failure to comply with these regulatory practices would be very costly for the company resulting in fines, remediation costs, and reputational..... Read More

Any business is formed on relationships and partnerships between businesses, with each focused on their own core competencies. ISV’s specialize in building industry-leading solutions that meet customer demands and needs. But as a software vendor, they need help with reaching the right customer at the right time and building a strong..... Read More

Enhancing Microsoft Dynamics AX for Complex Regulatory & Quality Requirements of Life Sciences Life science companies are facing challenges in response to an increasingly complex regulatory environment. These businesses have to address various requirements that span across geographies, business activities, and processes. Failure to comply with these regulatory practices would..... Read More

Computer system validation (CSV) is the process of providing a high degree of assurance through documented evidence that a computer system consistently meets its pre-determined or intended use or quality attributes such as accuracy, security, reliability, and functionality. A computerized system can include hardware, software, its peripherals, interfaces, equipment, users..... Read More