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Considerations for safety data migration methods

European Pharmaceutical Review

Pharmaceutical companies regularly transfer databases as they shift to new systems or change service providers in pursuit of higher quality and increased efficiency. In this role, Graeme is responsible for all pharmacovigilance (PV) systems that facilitate adverse event data collection and reporting.

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Data Integrity in the Pharmaceutical & Life Sciences Industry

Viseven

Data integrity isn’t a software, service, or product; it encompasses various solutions contributing to improved data maintenance and quality. Importance of Data Integrity in the Pharma Industry It takes just one wrong data entry, breach, or incident for patients and clients to lose your trust.

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How using AI in clinical trials accelerates drug development

Pharmaceutical Technology

But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Here are some ways companies are using AI in clinical trials. Adverse event detection Adverse events, or unexpected side effects, are a crucial aspect of clinical trials.

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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. Dealing with out-of-specification results Laboratory result out-of-specification events are a common occurrence in the quality control process. Checkout sample preview s.

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Deviation investigation guidelines in the pharmaceutical industry

GMPSOP

Deviations are unusual or unexplained events that can potentially impact product quality, system integrity, or personal safety. The fundamental difference between a planned and unplanned deviation is that the planned deviation is raised intentionally to improve a system, while the unplanned deviations are unexpected events or incidents.

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Guideline for Excel spreadsheet validation

GMPSOP

Excel spreadsheets are widely used in pharmaceutical operations, from simple data entry in the registers to complex data processing using functions and formulas. This would involve typical day-to-day tasks, such as data entry, calculations, generating reports, or any other regular function the spreadsheet is intended for.

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How to perform operational qualification – step by step

GMPSOP

The data entry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc. The FDA sets stringent requirements for operational qualification for critical equipment and systems to ensure the safety and efficacy of pharmaceutical products.