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.
Blog
Definition Validation Master Plan is an approved written plan of objectives and actions stating how and when a company will achieve compliance with the GMP requirements regarding validation. It is a document which defines the intentions and the methods that are related with validation of facilities, utilities, system, equipment, instruments, materials, analytical methods, It Systems, cleaning procedures
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
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
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