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Life Sciences Blog

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Life Sciences Blog

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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/Imported_Blog_Media/EUDRALEX-Volume-4-Annex-11-compliance-checklist-and-future-prospects-1.png

EudraLex Volume 4 Annex 11: compliance checklist and future prospects

What is EudraLex Volume 4 Annex 11? EudraLex Annex 11 serves as a reference document within the European Union‘s pharmaceutical industry. It provides...
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Annual Product Quality Review (APQR / PQR) in Pharma: importance, benefits & challenges

Current regulations require written documentation for all existing products in the company; this documentation is known as the A nnual Product Quality...
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21 CFR Part 11 compliance checklist: does your system comply?

In the post-COVID pharmaceutical landscape, electronic records and signatures are indispensable, guided by the 21 CFR Part 11 compliance framework. This...
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What is the purpose of Periodic Reviews in CSV?

Current regulations require that manufacturing processes in the pharmaceutical industry be validated, and once validated, they must be continuously...
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Data migration in CSV: definition, purpose, and best practices

Ever wondered why it is necessary – and sometimes absolutely essential – to perform a Data Migration in computer systems, applications or software,...
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What is decommissioning in CSV?

Changes in business needs or technology are inevitable. They often lead to the retirement or “decommissioning” of computerized systems. ERP systems, for...
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10 things you should know before validating Computerized Systems

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