On April 2, 2026, the FDA issued a warning letter that should be on the desk of every Quality leader in life sciences. It cites several familiar deviations — but embedded in the findings is something ...

In highly regulated industries such as pharmaceuticals and biotechnology, manufacturing is about much more than producing a product. Companies must prove through clear documentation and testing that ...

AI is no longer a future concept in lifesciences, it’s actively being deployed across business processes from regulatory submissions to manufacturing monitoring to quality operations. But while ...

This panel discussion will focus on three major guidance initiatives currently shaping the future of computerized systems compliance, featuring insights from ISPE Steering Committee Americas members.

The regulatory environment for manufacturers of medical devices in the United States is about to change in a significant way. The implementation of the FDA QMSR final rule has led to the modernization ...

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Corrective And Preventive Action (CAPA) is often discussed as it is an alarming issue for the life sciences industry. Organizations consider its importance and try to deal with it better as CAPA's are ...

Quality Records and Documents – Non-Conformances (NC), Corrective Actions and Preventive Actions (CAPA), Change Requests (CR), Bill of material (BOM), Complaints, SOPs, Work Instructions, ...

When a company is issued an FDA 482 Notice of Inspection and FDA 483 Warning Letter, it must prepare and be ready for the long adventure it will have to take with the FDA. Receiving an FDA 482 means ...

Bringing medical devices to market is a highly complex, challenging, and regulated process. Medical device manufacturers bear the responsibility of ensuring the safety and effectiveness of their ...

Organizations must develop a written method to approve papers for sufficiency prior to issuance. Documents should be reviewed, updated as needed, and re-approved. Determine the changes and the current ...

ISO 13485:2016 is an international standard for medical device manufacturers and providers of quality management systems. ISO 13485:2016 is not a law or regulation and is voluntary, while FDA 21 CFR ...