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Dangerous data delays – a real-time problem

pharmaphorum

Delayed clinical trial data delivery is a growing problem for pharmaceutical companies and one that can have catastrophic consequences for the development of their promising pipeline candidates. But there are ways to improve this situation, as Remarque Systems’ recent Is a lack of real-time data holding trials back?

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Intelligent Automation in Pharmaceutical Industry (AI & ML)

PharmaShots

The article focuses on the integration of automation with Artificial Intelligence (AI) and Machine Learning (ML). This article provides an informative account of intelligent automation, the key differences between AI & ML, their importance, and a potent eight-step roadmap to implementation. With the impelling Pharma 4.0,

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Data Integrity in the Pharmaceutical & Life Sciences Industry

Viseven

Good record management practices, quality risk management, and robust compliance frameworks are standard procedures in industries like pharmaceuticals and life sciences. 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.

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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.

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Deviation investigation guidelines in the pharmaceutical industry

GMPSOP

This article will explore more elements of unplanned deviations than planned deviations. incorrect data entry). This article mainly explored the management practices of unplanned deviation and the investigational approach to unplanned deviations. It is likely to be caused by human error or another isolated event.

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What are the elements of quality control process in pharmaceuticals

GMPSOP

. – Record or capture all generated raw data directly, promptly, and legibly. – Use traceable data sheets or sequentially numbered notebooks. – Date and sign or initial data entries on the day of entry. – Archive records so that they are protected, secured, and easily retrievable.

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Overview of GLP requirements on everyday laboratory operations

GMPSOP

The term Good (Control) Laboratory Practice G(C)LP describes the regulations and practices concerning pharmaceutical laboratory testing as part of Good Manufacturing Practice (GMP). This article will focus on G(C)LP due to its significance in everyday laboratory operations.