edata/(ee-day-tuh) * n. 1 facts or statistics used for reference or analysis. 2 the quantities, characters or symbols operated on by a computer.
integrity/(in-teg-ri-ti) * n. 1 the quality of being honest and morally upright. 2 the state of being whole or unified.
Your company is the sum of its data. Protect your data, make it work for you, and you succeed. Lose control of your data and face the consequences.
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For a pharmaceutical or medical device company, edata integrity failure can mean a delayed product introduction, or the release of a flawed product into the market. For a hospital or a physician's office it can mean the theft or loss of personal patient data that means bad headlines and heavy fines.
But you can harness your data. CROs, for example, can speed clinical trials with Electronic Data Capture (EDC). And for any company there is the opportunity to leverage data to improve operational efficiency and satisfy regulators.
The list of edata compliance laws is long: HIPAA (HHS), Sarbanes-Oxley (SEC), 21 CFR Part 11 (FDA), Ediscovery (Federal Rules of Civil Procedure), to name but a few.
That's why we've introduced EdataIntegrityReport. Every two weeks you'll benefit from:
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Case studies about what's really working for drug and device companies.
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Expert insight and analysis from your colleagues who divulge their own proven best practices when it comes to risk management, risk assessment and other edata integrity challenges.
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Independent analysis from the leading consultants in the field who share their birdseye view of success stories you can learn from and damaging failures you can avoid.
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The latest regulatory news and industry trends.
No fluff. No hype. You'll hear from leaders like you working every day to improve edata integrity.Edata Integrity Report is written by veteran industry journalist Michael Causey. For nearly a decade he's been covering the convergance of etechnology and healthcare. As former Editor of FDANews' Part 11 Compliance Report and PharmaDevice IT Report, Causey has been steadily providing actionable analysis and reporting on EDC, Esignatures, Ediscovery, Risk Assessment and Risk Management, and the competitive battle to get potential blockbuster drugs and devices to the market quickly, safely and efficiently. Causey has also written extensively about Ehealth Records, Emedical Records, CAPA programs, GMP, QA, QS and how drug and device companies large and small are harnessing the benefits of etechnology without falling for the spin.
Got a story idea? Something you want us to look into? Email Michael directly at mcausey@edataintegrityreport.com.
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