Guides

Data Standardization

Data Standardization: How It’s Done & Why…

See how data standardization and subsequent enforcement of data standards enable organizations to…

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electronic health records

What Is an Electronic Health Record (EHR)?

See why physicians and staff agree almost universally that electronic health records save them…

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pharmacokinetics

Pharmacokinetics

Pharmacokinetics plays a vital role in pharmacology for drug formulation; see how the principles…

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protected health information

What Is PHI?

Individuals share PHI to partake in healthcare services; see how PHI protection is a priority of…

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good manufacturing practice

What Is GMP?

See how GMP guidelines enable consistent product quality, help identify risks associated with…

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laboratory information management systems

Laboratory Information Management Systems (LIMS)

See how Laboratory Information Management Systems (LIMS) streamlines a fundamental lab process…

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iq oq pq

A Guide to IQ, OQ, and PQ in FDA-Regulated…

See how OQ, IQ, and PQ provide a proven validation framework that enables the quality and safety…

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eu mdr

EU MDR: European Union Medical Device…

See how the EU MDR harmonizes requirements across the European Union and provides long-term…

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electronic data capture

Electronic Data Capture Fundamentals

See how electronic data capture systems improve information management and analysis and…

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21 CFR Part 820

21 CFR Part 820

See how 21 CFR Part 820 has the added benefit of embedding GMP that enable safety and optimize…

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cdisc

CDISC and CDISC Standards

Learn about CDISC, a non-profit organization that develops data standards for clinical data…

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good clinical practice

Good Clinical Practice

See how Good Clinical Practice guides studies to ensure that the highest quality data is…

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electronic consent

Electronic Consent: Definition and How It Works

Learn about electronic consent, considered safe and effective in protecting subjects’ rights in…

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gxp

GxP

See how understanding, implementing, and maintaining GxP standards is an effective way to provide…

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