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Typical GMP documentation in a quality control laboratory

GMPSOP

In other word, you need GMP documentation specially developed and used for your laboratory to guide you through everything you do in the lab. Depending on the objective of the lab, the need for GMP documentation will change for the laboratory. The significance of well-designed GMP documentations is immense.

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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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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. to generate useful information from the initial data points. Additional documents included each month. Why is Excel spreadsheet validation required?

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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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The Best 24 Easy-to-Use AI Tools

FADIC

Designed to enhance how you manage tasks and documents and collaborate with your team, Notion AI offers an intelligent and intuitive platform for managing projects, creating databases, and generating insightful reports. Presentations supporting AI tools: 16.

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Data integrity considerations in Pharma and Life Sciences

European Pharmaceutical Review

This can be achieved by implementing electronic systems with built-in controls to maintain data integrity, audit trails and access controls. Good documentation practices. Following good documentation practices (GDP) throughout all stages of data generation, collection, analysis and reporting is vital.

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Achieving commercial excellence with data-driven decisions

pharmaphorum

Apart from manual transfers of documents between colleagues, the data is relegated to one’s hard drive and can’t be queried at scale to evaluate performance or to inform future projects. This requires extensive planning; such wide-ranging analyses take years to orchestrate and include countless data sources.