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.

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GMPSOP

DECEMBER 24, 2023

. – 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, secure, and easily retrievable.

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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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Documentation Method Validation Packaging Data Entry 52

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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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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