FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to […]
The topic of supply chain integrity and security is relatively new in Pharma, having gained prominence in recent years for the reasons described above. Breach of security related to criminal activity is where the issues are most visible and enforcement activity is actively taking place around the globe. In parallel, if we are looking for […]
How do you know if you are pressing the right key, let alone performing the best test?
Including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.
Risk management in the global economy is a highly challenging field for risk managers from any part of the world. With most of the world’s countries almost becoming part of the global economy in this era of globalization; it is emerging that risks that apply to one part any one nation’s or group of nations’ […]
The answer to how risk management is important to project success is best illustrated by the fact that no project has ever succeeded without proper risk management. In other words, project management into which risk assessment has not gone in is as good as a doomed one. Risk management’s importance to project success can never […]
Understanding and implementing risk management methods and tools is crucial for the pharmaceutical and life sciences industries in view of the fact that errors in this area can lead to dangers for human life. Since any mistake in any chain of in this industry can lead to serious consequences; the FDA and other regulatory agencies […]
Key Takeaway: An understanding of what is accounting fraud and how to prevent financial statement fraud is an important lesson for managements across the world, in any kind of business. In the simplest terms, accounting fraud is the practice of manipulating accounting records so that the actual financial condition is hid from the investors, the public […]
The role of packaging in food safety and security is paramount. Perhaps no other factor plays the role of packaging when it comes to ensuring food safety and security. The role of packaging in food safety and security can be understood at its barest from the fact that packaging saves the product from rotting, contamination […]
An environmental, health and safety (EHS) management and audit program is now a prerequisite for organizations in various kinds of business. Allied to the emergence of and developing along with the concepts of worker safety and corporate social responsibility; the environmental, health and safety audit is today a major component of an organization. Organizations that […]