Innovations and Emerging Technologies in the Regulated Environment of Pharma Effective training programs are essential for maintaining compliance, improving operational efficiency, and ensuring data ...

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 ...

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 ...

So, Quality Management System has produced a step-by-step process to help companies handle the CAPA process to get satisfactory results in adherence to ISO (International Standards Organization) FDA ...

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 ...

As the pace of digital transformation and automation accelerates, the need for a robust and lean risk assessment methodology for software is becoming more and more critical in the life sciences ...

The development of new medical devices or any new project brings a new set of risks. A Risk Management Plan (RMP) must be developed at the start of the Risk Management Process for a new project or ...

In the realm of Computer System Validation (CSV), risk assessment stands as a cornerstone in ensuring the safety, efficacy, and compliance of software systems, particularly in regulated industries ...

FDA (Food and Drug Administration) issued a draft guidance to offer recommendations on Computer Software Assurance (CSA) for automated data processing systems that are used as a part of medical device ...

The Sarbanes-Oxley Act (SOX) is a U.S. law that was passed in 2002 to protect investors by preventing fraudulent accounting and financial practices at publicly traded companies. The law's purpose is ...

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

The different processes involving multiple roles like supplier, production, manufacturer, and pieces of equipment for designing or marketing a product will inevitably invite some non-conformance ...