3 reasons why pharma and biotech companies are improving their documentation

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From the earliest phases of research and development to manufacturing and distributing new products, pharmaceutical and biotechnology companies are challenged by the sheer volume and complexity of the information they need to manage. They’re also heavily regulated.

Recognizing the importance of documentation to operational efficiency and compliance, industry leaders are improving its quality and consistency in these 3 key areas.

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Why the outcome of Yates shouldn’t bring document managers comfort

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You’ve probably come across the story: a commercial fisherman violated a law on what he was allowed to legally catch, and destroyed the evidence of his violation to avoid being charged. But instead of invoking local law and fining him, the feds charged him under the anti-shredding statue of the Sarbanes-Oxley Act.

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Improve documentation to drive down healthcare costs

Improve-documentation-to-drive-down-healthcare-costsFor many people it’s a problem to read and understand the confusing instructions that come with some medication. Last year over 125,000 Americans died simply because they didn’t take their pills or follow doctors’ orders. On addition to all those deaths, thousands more experienced continuing ill health or required additional hospitalization. Healthcare professionals call this “patient noncompliance,” and it’s a very expensive problem. In 2012 it cost the public an estimated $289 billion.

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The Big Payoff - Managing Financial Regulatory Documentation

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Did you follow the news stories from last week’s World Economic Forum? 2500 of the world’s top bankers and financial managers gathered in Davos, Switzerland, where they spent a lot of time discussing the challenges posed by increasing regulatory scrutiny. The big financial institutions are reluctantly bracing themselves to cope with more oversight.

I’m ambivalent about this. I hate the idea of being burdened with additional charges and fees, which is how some big financial services organizations will get consumers like me to pay their costs of compliance. But I like the other potential outcome, which is that the banks may be compelled to seek out ways to operate more efficiently.

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Begin your journey to better compliance documentation: getting started with the 6 Steps

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Last week we completed our series of 6 Steps to Better Compliance Documentation with the final step, Create Reusable Information. Each step in the series featured tips and ideas you can use to create documents that support employee performance while meeting the requirements of regulators. The 6 Steps are more than just good advice—they’re proven strategies distilled from the principles of the Information Mapping® methodology. Our professional services consultants use the 6 Steps on a daily basis to help clients across a wide range of industries improve the quality and effectiveness of their compliance documentation.

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6 Steps to Better Compliance Documentation: Create reusable information

Step 6: Create reusable information

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If you visit the Information Mapping offices, in our hallways you’ll see several big blue bins. They’re usually full of paper that’s waiting to be picked up for recycling. You probably have similar bins in your offices, since nowadays most organizations are doing their best to be good corporate citizens. Many of us recycle glass, plastic and metal at home, as well. Recycling these materials represents cost-effective and efficient use of resources.

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6 Steps to Better Compliance Documentation: Guide Users

Step 5: Guiding your users to the information they need

white-water-rafting

Have you ever gone on a white-water rafting trip? If you like outdoor adventure, it’s a great experience. The river is wild and beautiful, the rapids are thrilling, and paddling is excellent exercise. You can enjoy it all without ever wondering about where you’re going or which route will get you there. You don’t need to think about that because your raft is steered by a guide, an expert whose job is to make sure you enjoy the trip and reach your destination safely.

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6 Steps to Better Compliance Documentation: Consistency is Critical

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Step 4: Check for Consistency

Lewis Carroll’s Alice in Wonderland is a tale built on inconsistencies. In Wonderland, nothing is quite what it seems to be, and nothing remains the same for very long. Even Alice herself undergoes changes—the poor girl can’t keep from growing and shrinking. All the inconsistencies contribute to the story’s wonderfully disorienting “through the looking glass” feel. They help make Alice the timeless classic that it is.

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Recent comment in this post
Rehan Makki
Nice one.
Saturday, 23 June 2018 13:59
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6 Steps to Better Compliance Documentation: Take the User's Perspective

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Step 3: Organize Information from the user’s perspective

Have you ever noticed how easy it is for two people to look at the same situation, and yet see things very differently? Of course, if you’re married you know exactly what we’re talking about. If you’re unattached, all you need to do is turn on the news—this is a presidential election year, and the candidates’ differences of perspective are feature stories every day.

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6 Steps to Better Compliance Documentation: Categorizing Information

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Imagine for a moment that you’re a chef, and your specialty is preparing dishes without knowing which ingredients you’re using. How many customers do you think will patronize your restaurant? How long will it be until you’re offered your own cooking show on television?

Step 2: Categorize information by type and purpose

Would you enjoy being served a meal that was prepared by a chef who had no idea which ingredients he was using? None for me, thanks—it would probably upset my stomach. Of course, if you’re a writer who creates a document without understanding the different types of information you’re working with, you’re putting your readers into much the same situation. Except that instead of indigestion, the result will probably be non-compliance.

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