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 ...

Companies in the life sciences, food, and cosmetics industries are all too aware of how fickle the market is, how dynamic their studies and those under investigation are, as well as their timelines ...

Documents and records prove that the company procedures align with compliance and regulation practices while designing, developing, and managing the life sciences products. It is a systematic process ...

The FDA is proposing to modify the requirements of its Good Manufacturing Practices (cGMP) regulations to align them with the requirements of the ISO 13485:2016 standard for medical devices. The ...

Development of AI/ML (Artificial Intelligence/Machine Learning) technologies has raised concerns regarding regulatory compliance. CSA/CSV (Computer Software Assurance / Computer System Validation) ...

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

As the English saying goes, "Potato, Potato" doesn't translate well in the written form. Still, it's saying the same vegetable but with a different pronunciation, meaning it doesn't matter how you say ...

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 ...

PAT tools and technology solutions are continually evolving to become more user-friendly, advanced and reliable. These improvements are making it easier for organizations to adopt and integrate PAT ...

Change management is when an organization creates a step-by-step protocol to manage and implement modifications to products and processes. A change management plan is a protocol that implements and ...

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 ...

The Compliance Group Inc is organizing a series of webinars presenting an overview of the draft guidance. CSA Webinar Series Season 3, Episode-7 describes the establishing the appropriate record ...