The most frequently cited good clinical practice (GCP) violation is a failure to adhere to a study’s investigational plan. But there’s a straightforward solution to your protocol compliance woes. Hint: it doesn’t involve the disconnected, mostly paper-based systems currently used to manage clinical trials.
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Knowing if a manufacturing process needs to be verified or if it needs to be validated is often a conundrum for medical device makers. Learn the difference between the two compliance-critical activities and circumstances when each is required.
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The prospect of an inspection by the U.S. Food and Drug Administration (FDA) causes dread for many manufacturers. If gone poorly, an FDA audit can have serious consequences. For medical device companies, noncompliance often falls under design control and document management, two critical areas that intersect with the design history file (DHF). The best way to get through an FDA inspection is to always be prepared for one.
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Data integrity is closely related to organizational excellence. An expert explains best practices and mistakes to avoid.
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When you experience an event such as a product recall or low production rates, resolving these issues can be challenging. Your best bet is to have a road map that helps you get to the root of the problem and recover quickly.
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Life sciences manufacturing during COVID-19 has changed dramatically. That’s why we’ve worked with MedTech Association and MASSMedic to bring you a 10-part webinar series about how to scale and pivot during the pandemic.
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Cannabis supply chains need to deliver high-quality products with consistency and foresight. Using state compliance data, it’s possible to ensure supply networks and regulators have all the necessary information they need for greater visibility and collaboration.
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Besides cutthroat competition, manufacturers in the life sciences deal with strict regulatory and ISO quality requirements. Changes in processes need to be carefully managed to ensure that products stay safe and effective.
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As the COVID-19 pandemic escalated, urgency and adaptability became the theme for organizations as they were suddenly tasked with enabling their entire workforce to work remotely. This scenario has largely been the impetus for more companies accelerating their migration to the cloud.
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In pharmaceutical manufacturing environments, strict compliance to approved policies and procedures is essential to keep manufacturing operations in a state of control. Uncontrolled changes like deviations can affect the safety and reliability of products, not to mention the regulatory status of products, directly affecting public health and safety. This is what makes change control – and a paperless system – crucial.
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For regulated companies, there’s a lot riding on training. If someone isn’t trained, the life-saving products of life sciences companies can become life-ending products. An integrated training management system gives training managers a complete picture of what’s going on with training and what they need to do next to stay on track.
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Audits are essential to regulated industries. The type of audit, who conducts it, and which regulations and standards are involved are all important. The process has its own challenges which have only been exacerbated in the current environment.
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The race to develop a safe and effective vaccine against COVID-19 is on, and it has everyone talking. This is the second of a three-part series on the fundamentals of immunization.
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Life sciences companies are migrating the cloud. To be successful with cloud compliance in a regulated environment, it’s important to understand the key challenges and know how to address them. While cloud host providers offer security features, it is your organization’s responsibility to confirm the provider is compliant.
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Supplier audits are the standardized testing of the manufacturing world. Suppliers and manufacturers are held to high quality standards and both must adhere to them to ensure final products are safe and effective. The key to this is a thorough supplier audit in which the supplier and manufacturer work together to improve quality throughout the supply chain.
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Design control plays a key role in producing a successful medical device or IVD tool in initial development and through its lifecycle. Learn some tips on how to approach a design control strategy from either FDA or ISO perspectives.
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The race to develop a safe and effective vaccine against COVID-19 is on, and it has everyone talking. Inoculation,vaccination and immunization are terms that are often used interchangeably, but have very different meanings.
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Medical device manufacturers tout ISO 13485 certification as proof that their quality management systems (QMS) and products are up to snuff. But what does compliance to the standard entail? Get answers to the most frequently asked questions about the world’s most widely used QMS standard for device companies.
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Discoveries and new opportunities are expanding across the industrial spectrum. At the same time, more businesses are modernizing their operations to benefit from scientific and technology innovation. The core of all this progress and growth is the cloud.
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Optimizing shop floor safety practices is as straightforward as abiding by five fundamental manufacturing safety tips. Learn how the right ideology can enable a manufacturer to establish effective shop floor safety practices and extend a safety-centered mindset across the entire enterprise.
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