Quality risk management implementation identifies and manages risks; under normal circumstances the risk-based approach to the validation of computerized systems should eliminate the risks to the system, or should at least reduce the risks to a tolerable level. (This tolerable level must naturally be defined prior to the execution of the risk analysis).
Are you sure your IT infrastructures are fully qualified, or is it possible that your methodologies missed some vital detail along the way? Perhaps you know you're good at maintaining infrastructure compliance, but your organization is about to reach its operational limits. Either way, it's time for a serious change.
Data integrity is an ever-increasing concern in life sciences, with medical device manufacturers feeling much of the conformity backlash. There continues to be heightened regulatory focus on diverse cybersecurity topics, including data integrity.
Companies that are regulated by the U.S. Food and Drug Administration (FDA) are required to perform validation to prove their software and systems are performing correctly. That’s why, with relatively few changes, we have been using Computer System Validation (CSV) for over 20 years in the regulated sector. The FDA’s first Principles of Software Validation, and later ISPE GAMP, continue to be the main go-to guidance and principles to help implement CSV.
Currently, digital transformation is a hot buzzword, and it’s something that everyone wants to be a part of, even if they don't understand what it is or what it means. So, what is digital transformation really?
To stay competitive, every organization should consider what they can do to improve the quality of their products and services. In fact, having a clear understanding of your overall quality management system to ensure that you meet or exceed your customer’s expectations is a compelling way to improve your business.
That’s where the ISO 9001 Quality Management System (QMS) comes in.
The ISO 9001 is an internationally-recognized QMS standard that can benefit every organization or company. As a powerful business improvement tool, the ISO 9001 standard sets forth a strong QMS framework that produces many benefits for businesses.
The methodologies your firm employs in the creation of pharmaceuticals, medicines and similar products designed for human consumption are most likely unique. Even if you follow relatively common chemical or physical manufacturing procedures, for instance, you still have to make modifications that fit your specific product design standards.
