Key Characteristics of FDA Part 11 Compliance

Properly managing sensitive information to maintain privacy and security has become paramount in recent years. Today, pharmaceutical companies and medical device manufacturers are increasingly using the Internet to broaden their services making compliance with FDA regulation even more important.

Quality Management Steps of Risk Assessment

Quality risk management implementation identifies and manages risks; under normal circumstances the risk-based approach to the validation of computerized systems should eliminate the risks to the system, or should at least reduce the risks to a tolerable level. (This tolerable level must naturally be defined prior to the execution of the risk analysis).

Choosing the Most Effective IT Infrastructure Qualification Strategies

Are you sure your IT infrastructures are fully qualified, or is it possible that your methodologies missed some vital detail along the way? Perhaps you know you're good at maintaining infrastructure compliance, but your organization is about to reach its operational limits. Either way, it's time for a serious change.

Understanding Your Manufacturing with Critical Process Parameters

What Data Integrity Means to Device Manufacturers

Data integrity is an ever-increasing concern in life sciences, with medical device manufacturers feeling much of the conformity backlash. There continues to be heightened regulatory focus on diverse cybersecurity topics, including data integrity.

The Importance of the FDA's Upcoming Guidance on Computer Software Assurance (CSA)

Companies that are regulated by the U.S. Food and Drug Administration (FDA) are required to perform validation to prove their software and systems are performing correctly. That’s why, with relatively few changes, we have been using Computer System Validation (CSV) for over 20 years in the regulated sector. The FDA’s first Principles of Software Validation, and later ISPE GAMP, continue to be the main go-to guidance and principles to help implement CSV.

This is How Digital Transformation Can Transform Your Business

Currently, digital transformation is a hot buzzword, and it’s something that everyone wants to be a part of, even if they don't understand what it is or what it means. So, what is digital transformation really?

This is How ISO 9001 Improves Your Company's Quality Management

To stay competitive, every organization should consider what they can do to improve the quality of their products and services. In fact, having a clear understanding of your overall quality management system to ensure that you meet or exceed your customer’s expectations is a compelling way to improve your business.

That’s where the ISO 9001 Quality Management System (QMS) comes in.

The ISO 9001 is an internationally-recognized QMS standard that can benefit every organization or company. As a powerful business improvement tool, the ISO 9001 standard sets forth a strong QMS framework that produces many benefits for businesses.

How Do Medical Device Manufacturers Maintain Data Integrity?

Is cybersecurity something you consider when designing a new product? As medical devices become more and more interconnected, the data they generate, store and share becomes more exposed.