As per Health Canada Guidance on GMP, GUI-0001, Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of a drug across the product lifecycle . In other words, the risk Management is defined as the identification, analysis, assessment, control, and avoidance, minimization, or elimination of unacceptable risks .
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Biopharmaceuticals shall demonstrate at any time their compliance with Data Integrity (DI) requirements. We all know that data Integrity is not a new topic rather, it is an old concept made essential in today’s digital age.
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I was asked one day to explain and to describe my professional job. Based on my educations, my skills and job experiences, I used to deal with quality and Good Manufacturing Practices (GMP) principles in Biopharmaceuticals, Foods, and cosmetics. I finally considered to qualified myself to improve human being by collaborating to deliver a quality and validated product. Indeed, my professional activities help developing products that meet their intended specifications. How do I do that in day-to-day basis? I simply use to apply the following five (5) lifecycles principles.
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What is Cybersecurity?
According to The National Institute of Standards and Technology (NIST) of the U.S. Department of Commerce, Cybersecurity is the process of protecting information by preventing, detecting, and responding to attacks.
In other words, Cybersecurity is a set of actions taken by Companies, stakeholders and or other third-parties to reduce risk to systems and information in cyberspace. These actions combine all aspects of information security to address needs for Confidentiality, Integrity, and Availability (known as the “CIA triad”) with critical information infrastructure protections .
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Industry 4.0 refers to the fourth Industrial Revolution through the use of cyber-physical systems. It consists of using the digital technologies to make manufacturing more agile, flexible and responsive to customers.
Industry 4.0 digitizes and integrates processes vertically across the entire organization, from product development and purchasing, through manufacturing, logistics and service. All data about operations processes, process efficiency and quality management, as well as operations planning are available real-time, supported by augmented reality and optimized in an integrated network.
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