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Choosing the Right Writer for Your Documentation Project

In biomanufacturing, pharmaceutical by Alicia CheungLeave a Comment

Pharmaceutical technical writers are a broad collection of technical people including engineers, biologics, chemists, microbiologists, and even a few liberal arts majors. Nearly all writers share a passion for accuracy, completeness, robustness, compliance, and clarity. But what pharmaceutical companies need from their writers differs across projects, products, departments, and maturity. Some companies need document processors to manage redlines and facilitate approvals. Other companies need an expert to identify and address compliance or procedural gaps. Some companies need writers to compile, analyze, and summarize data for reports. And others need authors who can leverage data to tell a story, inform and instruct readers, or present a scientific perspective for a submission. Matching writer skills to project objectives is an important first step. Why?

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Understanding the Hidden Costs of Weak GMP Documentation and the Return on Investment for Strong GMP Documentation

In biomanufacturing, business, Generis, generis group, manufacturing, pharmaceutical, production efficiency by GenerisLeave a Comment

In your experience, when an organization has invested in proper documentation, what have the results been like? The results have been tremendous! We’ve seen organizations move away from poor compliance and low morale toward a quality mindset with excitement for innovation. We’ve opened career paths for promising writers who love challenge and have a desire to help patients through strong GMP documentation. Our clients have demonstrated returns on investment for our projects by lowering documentation-based costs, reducing turnaround times, reducing documentation-based errors, and shortening regulatory filing times. Documentation comes off the critical path for the first time! Lastly, we’ve seen our projects serve as a springboard for further innovation and enhancements. In a nutshell, our best results have been realized when GMP documentation is embraced as an opportunity and powerful mechanism to help companies advance new therapies for their patients. To learn more about GMP documentation, check out the ebook by Bulletproof below! 

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eBook: Medical Device Development Best Practices

In healthcare technology, innovation, manufacturing, medical device, medtech, operational excellence, product design, product development, Quality by design by GenerisLeave a Comment

With the American Medical Device Summit quickly approaching, we took the time to sit down with one of our industry partners, Stratos Product Development, to gather their thoughts on the biggest medical device development challenges and the best practices to overcome them. Check out the Stratos eBook to explore : Complications arising from a lack of proper documentation, and how to overcome them. Strategies to speed the product development process while effectively managing costs. Tactics to make product launches more predictable. Regulatory considerations that need to be factored into the medical device development process in the U.S. The benefits of outsourcing innovation. eBook, Medical Device Development Best Practices For more insights into medical device development, commercialization and manufacturing, join Stratos at the American Medical Device Summit 2016 taking place in Chicago on October 5th – 6th, 2016.

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