Pervasive Risks Based Validated Application Development – Taming the Elephant


Today’s market demand is for Oncloud Hosting, Mobility and Integration which calls in for an application development framework with Business Processes, technology, Infrastructure, Regulations and the Security in built.” The Elephant” regulations and risk of Noncompliance is a trepidation and pervasive throughout.
 
Taming of the elephant has been in practice in the East form 200 BCE. In India, Elephants were not only in warfare but also domesticated and employed in Agriculture. Is not elephant raring and domestication a high risk? How was the animal domesticated? The answer is the beast was trained and habituated to work in synchronization on known pervasive risks factors about the animal.
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Pharmaceutical Manufacturing in 2015 and Beyond


Pharmaceutical manufacturers walk a fine line balancing contradictory forces. They must think about new regulations versus increased outsourcing and expiring patents versus the expectation of sustained profitability, for example.
 
The bad news is that the rules imposed on the industry aren’t getting less complicated. And while it may keep compliance officers busy, regulations are just one of many forces eating away at manufacturers’ bottom lines. As brands go off-patent, pharmaceutical companies lose the luxury of high margins and are faced with fierce competition. As a result, they are forced to increasingly rely on outsourced active pharmaceutical ingredients (API) and expand into emerging markets to maintain and grow their revenue. That increased reliance on outside manufacturers, however, represents a loss of control – a concept which seems to run counter to tightening regulation. Movement into emerging represents another series of complications and challenges, including cost to serve new segments, security and traceability.
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Does Big Pharma Take Compliance Seriously?


Based on my conversations with clients, there is a strong desire by middle management to comply with rules and regulations within the pharmaceutical industry. Middle level marketing, legal and compliance professionals worry about security breaches, identity theft and leaking patient information. As a result, they often hold their firms back from adopting new technologies and forms of communications, such as social media, for fear of being out of compliance.
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Navigating the Affordable Care Act: Drug Sample Compliance


There is a compliance deadline looming this spring for pharmaceutical companies, on reporting drug sample distribution to the FDA. While some may take a head in the sand approach, the smart companies will get out ahead of this issue and have the tools in place to report their sample distribution, saving them from potentially costly fines.
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Pharmaceutical Companies and Compliance – The Many Levels of Enforcement


Compliance and quality go hand in hand. You can’t ignore one and expect the other. Pharmaceutical companies take compliance very seriously; it would be unreasonable to question whether or not they do. However, because compliance is a broadly encompassing term that in isolation is ambiguous, a better question to ask is, “Which aspects of compliance are taken seriously by sponsors and which are not?”
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Agile Software Development in Regulated Environment


For years now, pharmaceutical companies struggle with the adoption of various iterative software development methodologies for computer system applications that support regulated activities and must be validated. Industry best practices for computer system validation are structured around the standard “Waterfall” software development life cycle (SDLC) approach, in which there’s a clear linear progression, and the deliverables of each phase are completed before the team moves to the next phase of the SDLC. Iterative SDLC methodologies are based on multiple iterations of requirements definitions, software development, testing, and user experience with the system that lead to a refined software product that meets the users’ needs.
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