European Pharmaceutical Review

SEPTEMBER 26, 2023

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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Pharmaceutical Technology

JUNE 15, 2023

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.

Drug Development 52

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Viseven

SEPTEMBER 6, 2024

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.

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Data Entry Communication 52

GMPSOP

JUNE 28, 2024

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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GMPSOP

OCTOBER 28, 2023

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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GMPSOP

APRIL 19, 2024

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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Documentation Data Entry Communication Pharmaceutical Companies 52

GMPSOP

JULY 31, 2023

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.

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