validation Posts

Best Practices in Change Control: Taming the Winds of Change

Best Practices in Change Control: Taming the Winds of Change

Sandy Carson, Marketing Communications Manager, Pilgrim Quality Solutions

We witness the impact of Change Control every day, in the most mundane places. For instance, 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?
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Using Automation for Software Validation

Using Automation for Software Validation

Stanley Curtis, CTO and Senior Vice President, Software Engineering, Pilgrim Quality Solutions

It’s time to put down your pen and paper. Stop hoarding the mounds of paper artifacts that result from manual Computer System Validation (CSV). Free up your valuable resources for other operational tasks while safeguarding the results of your CSV. All of this is possible with automated and paperless validation tools for software validation.

The FDA requires computer systems validation for any software-driven components built into medical devices, or software used to design, build, or manufacture medical devices. The same holds true for software used in the manufacturing of pharmaceuticals, biologics, or other products or components for Life Sciences. Amazingly, some companies—large and small—still perform validation manually.
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Eliminate the Validation Bottleneck

Eliminate the Validation Bottleneck

LNS Research recently published a great blog post on the State of the Market for Software Validation in Life Sciences. Click here to read the full post from Dan Jacob, Research Analyst at LNS Research.

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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

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.

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