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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. Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon.

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Overview of GLP requirements on everyday laboratory operations

GMPSOP

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. All sampling procedures and plans must be documented. All written and updated by GMP experts.

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Achieving commercial excellence with data-driven decisions

pharmaphorum

Executing an effective commercial success strategy requires extensive planning and implementation within pharmaceutical companies that spans teams, functions, and geographies. Together, these groups compile vast amounts of data, including rich information on patient populations, target customers, and the competitive landscape.

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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. As clinical trials generate a massive amount of data, it can be challenging for researchers to manually review all of this data to uncover meaningful insights.

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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. Spreadsheets with different levels of GAMP category GAMP 3: These spreadsheets are used solely to produce paper documents. Checkout sample preview s.

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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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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.