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Data Integrity in the Pharmaceutical & Life Sciences Industry

Viseven

All of it is done to assure data integrity—the glue that holds together all measures and actions performed to keep the data safe, error-free, and complete. In our new article, you will learn more about data integrity in the pharmaceutical and life sciences industry and why maintaining it matters so much.

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Important factors to consider when working with CRFs

pharmaphorum

Well-designed forms must: Gather data that’s complete, accurate, and of high quality. Be unambiguous and allow for accurate data entry. Avoid gathering more data than what is needed. Provide form completion guidelines to reduce data capture and data entry issues. Avoid duplication. Get user feedback.

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Important factors to consider when working with CRFs

pharmaphorum

Well-designed forms must: Gather data that’s complete, accurate, and of high quality. Be unambiguous and allow for accurate data entry. Avoid gathering more data than what is needed. Provide form completion guidelines to reduce data capture and data entry issues. Avoid duplication. Get user feedback.

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What are the elements of quality control process in pharmaceuticals

GMPSOP

The analyst should ensure that the supervisor is notified as soon as an OOS event occurs, the sample is retained, and a documented investigation is commenced. – Document control records management and archiving systems. Additional documents included each month. You must document all sampling procedures and plans in use.

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Deviation investigation guidelines in the pharmaceutical industry

GMPSOP

Additional documents included each month. Additional documents included each month. This article will explore more elements of unplanned deviations than planned deviations. Additional documents included each month. Corrective and preventative actions should be implemented to avoid the recurrence of the deviation.

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Overview of GLP requirements on everyday laboratory operations

GMPSOP

This article will focus on G(C)LP due to its significance in everyday laboratory operations. Additional documents included each month. The points below outline some areas in the codes where G(C)LP regulations are embedded in the GMP regulations and guidance documents. Additional documents included each month.

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Guideline for Excel spreadsheet validation

GMPSOP

We had to ensure that those Excel spreadsheets were processing GMP data accurately and reproducibly so that our decision did not adversely affect the patient’s health. Excel spreadsheets are widely used in pharmaceutical operations, from simple data entry in the registers to complex data processing using functions and formulas.