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 ...

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 ...

In this session, Compliance Group (CG) will showcase a Siemens ISV low-code Mendix mobile app enabling Manufacturing and Quality leadership to answer questions they have struggled with for years – ...

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 ...

What exactly is Compliance documentation and how do you know if you are creating clear, concise, accurate content? In the life sciences field compliance documentation is crucial for meeting regulatory ...

We are excited to announce that Insulet will host our inaugural Lifesciences Polarion User Group meeting at their headquarters in Acton MA, just outside Boston. Join us for an interactive, educational ...

One of the most important requirements for regulatory compliance within the life science industry is the creation and maintenance of an audit trail. An audit trail is required for regulated ...

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 ...

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 ...

Computer Software Assurance 2024: CSx- Define your Variable and Assure your Validation conference has been meticulously designed to provide a platform for industry stakeholders to come together and ...

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 ...

FDA (Food and Drug Administration) issued a draft guidance to offer recommendations on Computer Software Assurance (CSA) for automated data processing systems that are used as a part of medical device ...