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How to implement good documentation practice in a GMP regulated plant

GMPSOP

Table of Contents Good documentation practice requires a system for control, implementation, maintenance and archival of GMP related documents and records. To implement good documentation practice and systems the site must assure that GMP documents and records are adequate, approved and in compliance with applicable GMP requirements.

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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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Why intelligent automation is the future for regulation

pharmaphorum

To improve data confidence regulatory executives should take a four-step approach to change how they: Collect Data: Life sciences organisations should utilise cloud-based solutions with global access that facilitates one repository with a single source of truth and eliminates the use of local file sharing and servers.

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Considerations for safety data migration methods

European Pharmaceutical Review

Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon. Once all cases have been entered and reviewed and any discrepancies resolved, the data transfer is considered complete and a data migration summary report should be issued.

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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. is a revolutionary AI tool transforming how businesses and organisations conduct video communications.

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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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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.