Regulatory Articles

Mass spectrometrists working in pharmaceuticals development tend to approach the issue of regulatory compliance with some trepidation. We know we can’t escape its considerable demands for our time and attention, and we’re willing to act accordingly to ensure that our instruments and procedures comply. Yet it often appears that requirements are expanding in both scope and detail. This month’s coauthor succinctly sums up the issue: “The FDA wants to see quality built into the product at the beginning of the development cycle because quality cannot be ascertained at the end.

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when 21CFR11 was signed into law, its scope was sorely misunderstood. The regulation’s premise was to maintain proper identifiers for electronic data relevant to product safety, purity and efficacy. Just as printed documents provided a paper trail through the product life cycle, computer records needed to create a similar electronic trail, identifying users, approvals and progressions that lead back to the original data. Conceptually there was nothing new about 21CFR11. In essence, it was a response to advances in the tools and equipment being used in the development, production and distribution of a pharmaceutical product. But the tracking of electronic records and signatures was an unknown entity that a majority of firms found intimidating and overwhelming.

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European Commission

Power source Raymond Hecker explains what's required to be 21 CFR 11 compliant, power-wise.


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. Pharmaceutical and biopharmaceutical enterprises continue to face complex regulations and increased scrutiny from regulatory agencies related to the safety and efficacy of their products—from discovery and license approval through o­ngoing supply to the consuming public. These complexities and increased scrutiny can result in large fines and production shutdowns, making “top floor” executives more concerned with day-to-day “shop floor” operations. Although the initial push to focus o­n production control activities follows o­n the heels of unsettling events, many pharmaceutical and biopharmaceutical manufacturing executives are discovering that information systems are the key to providing reduced costs and increased competitiveness in the face of increasing regulatory pressure.

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by Susanne Kienzle-Horn, Advisor, Clinical Research, SCRATCH, Germany

Subject diaries are used in about one-fourth of all clinical trials to collect data on primary and secondary endpoints.1 Part 1 of this four-part series on developing and implementing subject diaries compared and contrasted traditional paper and electronic diaries.2

In that article, we examined both methods in the context of existing FDA and ICH regulations and guidance for capturing diary data. We concluded that newer, electronic methods are in fact more compliant with FDA and ICH data standards than traditional paper diaries. The rest of this series focuses solely on electronic patient diaries (EPDs), in an effort to help clinical researchers better understand the process of implementing an electronic system to be used in their clinical trials.

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There are a number of reasons that your company might decide to utilize the services of an external regulatory affairs service provider. It may be appropriate to hire o­ne with expertise in a type of product/technology when your company does not have that expertise in-house. o­ne may be utilized when the workload of your internal Regulatory department is unusually high or while your company is interviewing to fill open regulatory affairs positions.

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In the year , we introduced Pyrosequencing™, a new technology for applied genomics. Using an enzyme-cascade system, light is generated as base pairs form during analysis of . Today, Pyrosequencing™ is the established solution for  analysis, enlightening researchers at companies and institutions worldwide. Pyrosequencing™ is also a publicly listed company, and o­ne of the “ Best Small Companies” worldwide, according to Forbes Global Magazine. And still, we are just getting started. Now, we promise to apply the same bright idea to sequence analysis. In a wide range of applications, Pyrosequencing™ will provide simple, fast and accurate identification of gene-specific sequences. Want to know how we can put your results in a new light, too?

CRAs now have to monitor sites’ compliance with FDA’s Electronic Record, Electronic Signatures regulation.For full article Click Here