August 27, 20191
Pharmaceutical Companies are using Artificial Intelligence to support their Pharmacovigilance Systems
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
March 12, 2017Like
Data Integrity Violation In Pharma
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
February 14, 2017Like
Volatility of Pharma and Biopharma in 2017
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
November 9, 2016Like
Does Computer System Validation Apply To You?
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
November 9, 2016Like
Why should life sciences companies choose Microsoft Dynamics?
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
September 2, 20161
Enhancing Microsoft Dynamics For GMP Compliance
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
July 21, 2016Like
Microsoft Partners: Improve Your Offering For Life Sciences
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
July 8, 20161
Microsoft Dynamics AX for Complex Regulatory & Quality Requirements of Life Sciences
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
July 8, 20161
Press Release – New Medical Device Clients For AXOQCS™
New Medical Device Clients For AXOQCS™: Rapid Self Test Inc. And Body Heat Pads Inc. AXOQCS™ is a complete business solution developed for Microsoft Dynamics AX that provides quality and compliance functionality for companies in the life sciences industry Milton, Ontario – (April 15, 2016): AXSource® Global, the leading Microsoft Dynamics™ Partner..... Read More
May 25, 2016Like
What Is Computer System Validation?
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