Software Validation

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July 21, 20201

5 Benefits of Artificial Intelligence in Healthcare

1. Take a selfie from your phone and receive a diagnostic Sounds crazy right? Our phone cameras are so detailed, and the quality is only getting better. This trend really complements dermatology and ophthalmology specialties. There are applications that have unique algorithms that can determine features as specific as jawline..... Read More
Pharmaceutical Companies are using Artificial Intelligence to support their Pharmacovigilence Systems
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
Data integrity pharma
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
Computer System Validation FDA
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
Microsoft Dynamics ERP For Life Sciences
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
Computer System Validation
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