Validation Posts

The Winds of Change Keep Blowing; Don’t Let Them Throw You Off Course: Practices in Change Control

The Winds of Change Keep Blowing; Don’t Let Them Throw You Off Course: Practices in Change Control

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

Take a trip down the grocery store aisle and you’ll quickly see packages and cans boasting “New and Improved Formula” for everything from soup to soap. It seems that manufacturers are constantly improving their products. But are they really better…or just different? The reality is, companies are changing their products. It doesn’t necessarily mean it’s a change for the better.

It could be that a vital ingredient is no longer readily available or is suddenly more expensive. It could be that the competition launched a smear campaign to discredit a product by claiming it’s unsafe or unhealthy. It could even be the manufacturer’s own attempt simply to make news.

Regardless, change is inevitable and impacts every business unit and process across an organization, including the Quality Management department. In fact, Change Control is a vital part of the quality manager’s job. The FDA has certain expectations of companies and, like it or not, documenting change is one of them that falls squarely on the shoulder of QA. (more…)

How to Build a Multi-Functional Validation Team

How to Build a Multi-Functional Validation Team

Mark Crawford

The current practice within cGMP-regulated industries is that validations are conducted by teams of people, working cooperatively toward a common goal. Quality-driven organizations have come to recognize the limitations of clearly defined roles, responsibilities, and organizational boundaries and are starting to use multifunctional teams that integrate all stakeholders’ efforts toward a validation project. (more…)

FDA Upgrades Human Factors and Usability Expectations

FDA Upgrades Human Factors and Usability Expectations

Mark Crawford

Less uncertainty from the FDA, and a smoother 510(k) submission process, is always a good thing. That’s why most medical device manufacturers (MDMs) support the new FDA guidance document released on June 22 that will improve the safety of medical devices by conducting more human factors engineering.

The 37-page document, entitled “Applying Human Factors and Usability Engineering to Optimize Medical Device Design,” states that its “recommendations are intended to improve the usability of devices to reduce use error, injuries from medical devices, and product recalls.” (more…)