The life sciences industry has primarily focussed on quality practices and procedures to focus on the customer needs and upon their internal efficiency to compete effectively in the market with goods ...

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 ...

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 ...

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 ...

Version control is required for documents involving processes, procedures, and best practices that undergo revisions and redrafting to maintain regulatory guidelines and compliance. Throughout the ...

Suite # 501 & 502,Pratima Arcade, HIG - 42, 43, KPHB 6th Phase Main Road, ...

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

This case study delves into the successful accomplishments of Compliance Group (CG) in the optimizing and validating computerized applications that support Good Laboratory Practices (GLP) processes ...

Information flow is evident in the life sciences industry, resulting in more unstructured data. Therefore, quality data is vital for effective and compliant operations as the industry's regulations ...

There may be some misunderstanding surrounding FDA 21 CFR Part 11 when it comes to regulatory compliance for manufacturers of medical devices. We have discovered a major pitfall here: Many businesses ...

The significance of FDA Computer Software Assurance (CSA) cannot be overstated when it comes to laboratory systems in today's technological era. Embracing the CSA methodology is crucial as it promotes ...

From hearing aids to ultra-tech pacemakers, the medical device industry is a ground-breaking and innovative field full of opportunities. Though the manufacturers are passionate about delivering ...