Tag Archives: Life Sciences

Managing QMS Validation the Modern, Efficient Way

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With every trip to our local pharmacy, grocery store or corner variety shop, we pass hundreds of products that have reached the shelves only after a lengthy process designed to ensure their quality.

It’s not something the everyday consumer thinks much about. But without this crucial element of the manufacturing process, we would never be able to trust the quality of the many products whose high standards we take for granted. It’s quite easy to envision the catastrophes that would result.

Core to the process of ensuring quality is the concept of validation. This is the process whereby pharmaceutical manufacturers provide objective, documented evidence that their processes, equipment and computerized systems are checked and validated to ensure the quality of their medicines and medical devices.

Central to the validation journey is the required documentation produced with each step. To satisfy regulators, companies must record evidence to prove what work was … Read more...

Four Reasons Why Life Sciences Organizations Are Moving Their QMS to the Cloud

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Life sciences organizations, including pharmaceuticals, and medical device manufacturers, constantly look for ways to reduce risk, increase patient safety, and achieve operational excellence. To be successful in these three areas, pharmaceutical and medical device manufacturing companies need to have robust management systems in place. This is even more critical than in other industries where the breadth of regulatory requirements is not as vast.

Transforming their QMS to the cloud can help them achieve these strategic objectives. Along this digital transformation journey, software validation can be a challenge with varying degrees of intricacy across organizations. Causes can range from lack of experience and expertise to the complexity of internal and external stakeholders involved. Ultimately, no one wants to receive a 483 from the FDA due to noncompliance with 21 CFR 11, which will put an organization in a bind and ultimately impact patient safety.

As pharmaceuticals and medical device manufacturers look … Read more...

4 Best Practices for Life Science Manufacturers to Manage Risk

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Managing risk for life science organizations is often seen as simply a way to achieve and maintain industry compliance, and not as a means to improving operational performance.

That’s far from the perception in other industries, where effective risk management also supports continuous improvement and competitive differentiation.

Industry leaders in risk management are committed to continuous improvement programs, which drive down risks on existing products. The reality today is that the changing nature of risks requires adopting effective strategies to properly prioritize and mitigate them.

Arguably life science manufacturers should adopt a similar approach that takes advantage of best practices from across industries.

To that end, manufacturers should focus on:

Using a single unified framework for risk management

A unified framework allows the ability to compare risks, and execute continuous improvement measures. Many possible risk models exist, such as failure modes/failure effects/causes/controls/verification, or hazards/harms/controls/consequences. A unified model allows manufacturers to … Read more...