For too many FDA-regulated companies, internal audits are just another procedural item to check off. It may get onto the calendar, but rarely gets circled as a high priority. The result? A moment of panic when you realize you only have a few weeks to complete your program.
This mindset ignores the reason regulators require internal audits in first place––to help you teach yourself how to identify and address issues before they need to do it for you.
A well-run internal audit doesn’t just provide protection, it lets you revisit your quality system and compare it to current regulations.
Have new requirements created gaps in your system that need to be addressed?
Are there opportunities to be more efficient?
These are the advantages of building an internal audit process that gives you valuable information in return for the work you invest in it.Continue Reading
This article is an abbreviated introduction to Chinmoy Roy's "The Data Integrity Triad." Read the full article on LinkedIn here.
The rise in Data Integrity warning letters are forcing companies to make a beeline for obtaining an understanding of data integrity. A close examination of management objectives where data integrity issues have unraveled indicates that they have been driven by the self-interest of profit.
They hesitate to switch out older equipment for newer ones with technical controls to enforce data integrity. They also hesitate to provide the required level of personnel resources for regular audit trail reviews, investigation of data integrity issues etc.
While regulatory agencies are actively hiring computer savvy personnel familiar with the intricacies of electronic data, business expediency dictates pharmaceutical industry management to shadow those efforts by ensuring that adequate budgets are allocated to hire personnel with the right blend of IT and compliance expertise.Continue Reading
The 21st Century Cures Act signed into law in December of 2016 attempts to build on FDA’s efforts to advance medical product innovation and improve patient access to treatments while continuing to rely on high-quality evidence to evaluate safety and effectiveness.
The new law includes a number of important provisions specifically relevant for medical device manufacturers, including a streamlined process for exempting certain Class I and II devices from premarket notification requirements and allowing for revised regulatory standards for high-risk device accessories.
The newly passed law also expands the list of diseases for which the humanitarian device exemption (HDE) may apply, expedites the review process for breakthrough devices, and changes the agency’s authority to regulate particular types of medical software.Continue Reading